Horiba Instruments Incorporated
Canton, MI, US
HORIBA INSTRUMENTS INCORPORATED appears in FDA device records in Canton, MI. FDA records list 89 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 126 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
6 namesFDA records resolved to Horiba Instruments Incorporated carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Abx Diagnostics510(k), recall
- Horiba Instruments, Inc dba Horiba Medicalenforcement report, recall
- Horiba Instruments, Inc.510(k), enforcement report, recall
- Medtest Holdings, Inc.enforcement report, recall
- MedtestDx, Inc.enforcement report, recall
- Pointe Scientific, Inc.,510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 89FDA records hold 89 510(k) clearances for Horiba Instruments Incorporated between 1981 and 2007. The busiest year on record is 1981, with 14. The most recent is 2007, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 14 |
| 1982 | 4 |
| 1983 | 5 |
| 1984 | 2 |
| 1985 | 6 |
| 1986 | 4 |
| 1987 | 3 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 2 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 4 |
| 1996 | 2 |
| 1997 | 9 |
| 1998 | 1 |
| 1999 | 5 |
| 2000 | 4 |
| 2002 | 3 |
| 2003 | 6 |
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K070757 | MICROPROTEIN REAGENT SET | JGP | Substantially Equivalent | |
| K062118 | POINTE 360 | CFR | Substantially Equivalent | |
| K070251 | CARBON DIOXIDE LIQUID STABLE REAGENT | KHS | Substantially Equivalent | |
| K070207 | MULTI-ANALYTE CHEMISTRY CALIBRATOR | JIX | Substantially Equivalent | |
| K070504 | AMMONIA/ALCOHOL CONTROL SET | JJY | Substantially Equivalent | |
| K061377 | APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS | MSJ | Substantially Equivalent | |
| K051646 | ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH | JGS | Substantially Equivalent | |
| K040391 | TOTAL BILIRUBIN REAGENT SET | CIG | Substantially Equivalent | |
| K031539 | HEMOGLOBIN A1C REAGENT SET | LCP | Substantially Equivalent | |
| K023860 | MICROALBUMIN REAGENT SET AND CALIBRATORS | DDZ | Substantially Equivalent | |
| K030799 | MICROS 60 | GKZ | Substantially Equivalent | |
| K024006 | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE | JBF | Substantially Equivalent | |
| K030144 | MODIFICATION TO PENTRA 60 AND PENTRA 60C+ | GKZ | Substantially Equivalent | |
| K024002 | PENTRA 80 | GKZ | Substantially Equivalent | |
| K023396 | AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) | CIJ | Substantially Equivalent | |
| K022200 | PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 | GKZ | Substantially Equivalent | |
| K014203 | ABX MICROS 60 HEMATOLOGY ANALYZER | GKX | Substantially Equivalent | |
| K003677 | ABX PENTRA 60C+ HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | |
| K002199 | MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET | CFR | Substantially Equivalent | |
| K002646 | ABX MICROS CRP | GKZ | Substantially Equivalent | |
| K002651 | C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET | DCK | Substantially Equivalent | |
| K993590 | FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET | LCP | Substantially Equivalent | |
| K992511 | ABX PENTRA 60 HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | |
| K991839 | ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | |
| K992002 | AUTOHDL CHOLESTEROL REAGENT SET | LBR | Substantially Equivalent | |
| K990311 | VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | |
| K981978 | AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR | MRR | Substantially Equivalent | |
| K973588 | LIQUID ALKALINE PHOSHATASE REAGENT SET | CJE | Substantially Equivalent | |
| K973157 | LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET | JQB | Substantially Equivalent | |
| K973589 | LIQUID LDH-L REAGENT SET | CFJ | Substantially Equivalent | |
| K972725 | ALCOHOL REAGENT SET | DIC | Substantially Equivalent | |
| K971754 | LIQUID GLUCOSE (HEXOKINASE) REAGENT SET | CFR | Substantially Equivalent | |
| K972671 | BUN (LIQUID) REAGENT SET | CDQ | Substantially Equivalent | |
| K970933 | AUTO HDL CHOLESTEROL CALIBRATOR | JIS | Substantially Equivalent | |
| K970781 | LIQUID GLUCOSE (OXIDASE) REAGENT SET | CGA | Substantially Equivalent | |
| K970560 | URIC ACID (LIQUID) REAGENT SET | KNK | Substantially Equivalent | |
| K961588 | TOTAL IRON (NITRO-PAPS) REAGENT SET | JIY | Substantially Equivalent | |
| K961431 | LACTATE DEHYDROGENASE REAGENT SET | CFJ | Substantially Equivalent | |
| K940735 | LIQUID AMYLASE (CNPG3) REAGENT SET | CIJ | Substantially Equivalent | |
| K941287 | LIQUID ALT(SGPT) REAGENT SET | CKA | Substantially Equivalent | |
| K941132 | LIQUID AST (SGOT)REAGENT SET | CIT | Substantially Equivalent | |
| K935463 | CREATINE KINASE-MB (CK-MB) REAGENT SET | CGS | Substantially Equivalent | |
| K930475 | LIQUID AMYLASE REAGENT SET | JFJ | Substantially Equivalent | |
| K930660 | CREATINE KINASE (CK) REAGENT SET | CGS | Substantially Equivalent | |
| K920449 | POINTE 750 GLYCOMETER | LCP | Substantially Equivalent | |
| K921625 | CALCIUM-ARSENAZO III REAGENT SET | CIC | Substantially Equivalent | |
| K914873 | DIAZO COLORIMETRY, BILIRUBIN | CIG | Substantially Equivalent | |
| K910158 | AMYLASE | JFJ | Substantially Equivalent | |
| K896812 | CARBON DIOXIDE REAGENT | KHS | Substantially Equivalent | |
| K896590 | CARBON DIOXIDE REAGENT | KHS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1827821 | 1827821 | HORIBA INSTRUMENTS INCORPORATED | 5449 Research Dr, Canton, MI 48188 US | 2026 | and 88 more, listed in full below |
| 2086725 | 3002698356 | HORIBA INSTRUMENTS INCORPORATED | 9755 Research Dr, IRVINE, CA 92618 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- DDZAlbumin, Fitc, Antigen, Antiserum, Control
- DKCAlcohol Control Materials
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- CGXAlkaline Picrate, Colorimetry, Creatinine
- DRRAmplifier And Signal Conditioner, Biopotential
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- CDLBerthelot Indophenol, Urea Nitrogen
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- DKBCalibrators, Drug Mixture
- DLJCalibrators, Drug Specific
- DNNCalibrators, Ethyl Alcohol
- JFJCatalytic Methods, Amylase
- GKZCounter, Differential Cell
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- DIFDrug Mixture Control Materials
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CEMElectrode, Ion Specific, Potassium
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JFYEnzymatic Method, Creatinine
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- DBFFerritin, Antigen, Antiserum, Control
- CGAGlucose Oxidase, Glucose
- JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
- CFRHexokinase, Glucose
- DGCIge, Antigen, Antiserum, Control
- GKXInstrument, Automated Platelet Counting
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CETOlive Oil Emulsion (Turbidimetric), Lipase
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- CHARadioimmunoassay, Corticosterone
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- CDPRadioimmunoassay, Total Triiodothyronine
- CIJSaccharogenic, Amylase
- GFSStandards And Controls, Hemoglobin, Normal And Abnormal
- DHRSystem, Test, Rheumatoid Factor
- DDGTransferrin, Antigen, Antiserum, Control
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
Showing 25 of 126| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2166-2024 | HORIBA custom configured fluorescence instrument, modular Fluorolog-QM | HORIBA custom configured fluorescence instrument has a laser safety defect. This custom configuration of the modular Instrument removed the primary light source and the excitation monochromator. A plastic cap was installed to plug the optical port, where a more durable beam stop should have been used. The defect may allow the class 4 laser beam to burn (or transmit) through the plastic cap to exit the protective enclosure. | Class II | Open, Classified | |
| Z-0119-2020 | Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944 | Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could be observed and a patient result could be declared abnormal by the instrument due to these interferences instead of normal result < 38 U/L (or < reference value used in your laboratory). | Class II | Terminated | |
| Z-0389-2019 | Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only. | Vials of the autoHDL/LDL Calibrator were shipped without a vial label. | Class III | Terminated | |
| Z-2286-2018 | ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes. | When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of the microalbumin may be elevated more than 10%. This increase may affect serum, plasma and urine sample types. | Class II | Terminated | |
| Z-0494-2018 | 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400 | The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm. | Class II | Terminated | |
| Z-0493-2018 | 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400 | The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm. | Class II | Terminated | |
| Z-1554-2016 | Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes. | Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system. | Class II | Terminated | |
| Z-1553-2016 | ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes. | Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system. | Class II | Terminated | |
| Z-0743-2016 | ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method. | Class II | Terminated | |
| Z-0742-2016 | ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives. | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method. | Class II | Terminated | |
| Z-0741-2016 | ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method. | Class II | Terminated | |
| Z-0740-2016 | ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry. | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method. | Class II | Terminated | |
| Z-0739-2016 | ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method of using a multi-step approach ending with a photometric end-point reaction. | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method. | Class II | Terminated | |
| Z-0738-2016 | The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives. | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method. | Class II | Terminated | |
| Z-2487-2015 | Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored aluminum seals Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood. | A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of the control after reconstitution, which could result in an out of specification result prior to the current reconstitution claim of 7 days. For this reason we suggest discontinuing use of the control set. | Class II | Terminated | |
| Z-2768-2015 | MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic. | Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute HNC/HEC, control values were shown to be out of range running on the high end. | Class II | Terminated | |
| Z-2063-2016 | Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2. | Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance manifesting itself by under recovery of Homocysteine in Controls and Patient Samples. The cause of this deterioration has been attributed to a loss of reductant activity in Reagent 1. Testing performed indicated that the affected lot is at the limit of acceptable clinical performance. This observation was consistent across the reportable range of the assay. For this reason, do not continue to use affected reagent lot. Test data generated to date will be acceptable where validity control specifiCations have been met. | Class II | Terminated | |
| Z-2764-2015 | Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE plastic cube containers, PP plastic caps. Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only. | Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance. | Class III | Terminated | |
| Z-2773-2015 | Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill. | Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications. | Class III | Terminated | |
| Z-0856-2015 | Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is a software application developed by HORIBA Medical intended to receive, store, and manage Startup, Patient, and Quality Control (QC) results from an ABX Micros 60 Hematology Analyzer or ABX Micros CRP 200 Hematology Analyzer. Only one instrument connection is allowed per each Lite DM workstation. The Lite DM application runs on a PC within a Windows Operating System platform. Data transmitted from the instrument to the Lite DM workstation is a Serial RS-232 unidirectional ABX Format communication. The Lite DM can act as a standalone data manager for data received from the instrument, or allow transmission of this data to a Host (LIS Laboratory Information System or EMR Electronic Medical Record system). Following the completion of each blood sample analysis performed on the connected HORIBA Medical hematology analyzer, results are then communicated (uni-directional) to the Lite DM workstation. Results received will display to the user in a specific color coding format indicating any normal or panic reference range violations. Results are then rejected or accepted by the user for final reporting - formatted to guidelines stipulated by CLIA. At no time are any results interpreted; only reported for review and appropriate action. | HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of a software bug related to the potential for results received being applied to the wrong order in the Lite DM Worklist. This bug has not been seen in software versions above V2.0.0.19 IMPACT: Potential for results received being applied to the wrong order in the Lite DM Worklist. The is | Class II | Terminated | |
| Z-0902-2015 | ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) | HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm. The defect would result in a false high or false low results for HbA1c and false high results for magnes | Class II | Terminated | |
| Z-2316-2017 | MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. Product Usage: MedTest DX Controls Level 1 and 2 is lyophilized human based control sera for use in the quality control of diagnostic assays. Human sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control reproductivity. Concentration are available in 2 levels, normal (HNC) and elevated (HEC). | MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification. | Class III | Terminated | |
| Z-2692-2014 | ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium). | Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Horiba has updated the ABX PENTRA Magnesium RTU package inserts by removing the 7-day on-board stability claim and replacing it with a 1-day on-board stability claim. | Class II | Terminated | |
| Z-2121-2017 | Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap. | The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range. | Class III | Terminated | |
| Z-1173-2014 | Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers. | HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System. | Class II | Terminated |
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