Nova Biomedical Corporation
Waltham, MA, US
Nova Biomedical Corporation appears in FDA device records in Waltham, MA. FDA records list 129 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 36 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 129FDA records hold 129 510(k) clearances for Nova Biomedical Corporation between 1977 and 2026. The busiest year on record is 1992, with 10. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1979 | 2 |
| 1980 | 1 |
| 1981 | 1 |
| 1983 | 5 |
| 1984 | 2 |
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 3 |
| 1988 | 4 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 6 |
| 1992 | 10 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 5 |
| 1996 | 9 |
| 1997 | 1 |
| 1998 | 5 |
| 1999 | 2 |
| 2000 | 3 |
| 2001 | 1 |
| 2002 | 6 |
| 2004 | 2 |
| 2006 | 2 |
| 2007 | 4 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 3 |
| 2013 | 2 |
| 2014 | 3 |
| 2015 | 4 |
| 2016 | 3 |
| 2017 | 4 |
| 2018 | 7 |
| 2019 | 2 |
| 2020 | 4 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 3 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251281 | Nova Max Creat eGFR Monitoring System | SHB | Substantially Equivalent | |
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | CGX | Substantially Equivalent | |
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | LCP | Substantially Equivalent | |
| K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | CGX | Substantially Equivalent | |
| K232075 | StatStrip Glucose Hospital Meter System | PZI | Substantially Equivalent | |
| K221900 | Stat Profile Prime Plus Analyzer System | CHL | Substantially Equivalent | |
| K203549 | Nova Primary Glucose Analyzer System | CGA | Substantially Equivalent | |
| K200403 | Stat Profile Prime Plus Analyzer System | JGS | Substantially Equivalent | |
| K200204 | Stat Profile Prime Plus Analyzer System | GGZ | Substantially Equivalent | |
| K200349 | Stat Profile Prime Plus Analyzer System | CGA | Substantially Equivalent | |
| K193246 | Stat Profile Prime Plus Analyzer System | CHL | Substantially Equivalent | |
| K191626 | Stat Profile Prime ES Comp Plus Analyzer System | JFP | Substantially Equivalent | |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer System | JGS | Substantially Equivalent | |
| K182552 | StatStrip Xpress Glucose Hospital Meter System | PZI | Substantially Equivalent | |
| K182549 | StatStrip Xpress 2 Glucose Hospital Meter System | PZI | Substantially Equivalent | |
| K180340 | Stat Profile Prime Plus Analyzer System | CGA | Substantially Equivalent | |
| K180186 | Stat Profile Prime Plus Analyzer System | GGZ | Substantially Equivalent | |
| K180428 | Stat Profile Prime Plus Analyzer System | JGS | Substantially Equivalent | |
| K173797 | Stat Profile Prime Plus Analyzer System | CHL | Substantially Equivalent | |
| K181043 | StatStrip Glucose Hospital Meter System | PZI | Substantially Equivalent | |
| K170464 | StatStrip Xpress Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K171059 | Nova StatSensor Creatinine Hospital Meter System | CGL | Substantially Equivalent | |
| K160990 | Nova Max Uric Acid Monitoring System | PTC | Substantially Equivalent | |
| K163490 | StatStrip Xpress 2 Glucose Hospital Meter System | PZI | Substantially Equivalent | |
| K161856 | StatStrip Xpress Glucose Hospital Meter System | PZI | Substantially Equivalent | |
| K160156 | StatStrip Xpress Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K152986 | StatStrip Xpress 2 Glucose Hospital Meter System | PZI | Substantially Equivalent | |
| K151982 | Stat Profile Prime ABG Analyzer System | CHL | Substantially Equivalent | |
| K141907 | STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A | CHL | Substantially Equivalent | |
| K150461 | StatStrip Xpress Glucose Hospital Meter System | PZI | Substantially Equivalent | |
| K150281 | StatStrip Glucose Hospital Meter | PZI | Substantially Equivalent | |
| K142220 | Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) | CHL | Substantially Equivalent | |
| K132121 | STATSTRIP GLUCOSE HOSPITAL METER SYSTEM | PZI | Substantially Equivalent | |
| K131703 | NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM | CHL | Substantially Equivalent | |
| K131013 | FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K122688 | NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR | LFR | Substantially Equivalent | |
| K122435 | NOVA ONE BLOOD GLUCOSE MONITOR | LFR | Substantially Equivalent | |
| K112638 | NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS | NBW | Substantially Equivalent | |
| K112955 | NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM | KHP | Substantially Equivalent | |
| K110648 | NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM | CHL | Substantially Equivalent | |
| K100602 | NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS | KHP | Substantially Equivalent | |
| K101633 | NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH | JJY | Substantially Equivalent | |
| K091547 | NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS | NBW | Substantially Equivalent | |
| K070960 | NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM | CGA | Substantially Equivalent | |
| K070255 | NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 | NBW | Substantially Equivalent | |
| K070068 | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS | CGL | Substantially Equivalent | |
| K063821 | NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM | CGA | Substantially Equivalent | |
| K061830 | STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ | CIG | Substantially Equivalent | |
| K060345 | NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS | CGA | Substantially Equivalent | |
| K041016 | NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS | JJX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1219029 | 1219029 | NOVA BIOMEDICAL CORPORATION | 200 Prospect St, WALTHAM, MA 02454 US | 2026 | and 47 more, listed in full below |
| 3011979858 | 3011979858 | Nova Biomedical Corporation | 165 Lexington Rd, Billerica, MA 01821 US | 2026 | and 3 more, listed in full below |
| 3023162659 | 3023162659 | Nova Biomedical Corporation | 4 Enterprise Road, Billerica, MA 01821 US | 2026 | and 29 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHPAcid, Lactic, Enzymatic Method
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JJCAnalyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- GHSAssay, Carboxyhemoglobin
- KQIAssay, Fetal Hemoglobin
- LCPAssay, Glycosylated Hemoglobin
- GJCAssay, Sulfhemoglobin
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- MQMBilirubin (Total And Unbound) In The Neonate Test System
- CEKBiuret (Colorimetric), Total Protein
- JIPBlood, Occult, Enzymatic Method, In Urine
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- JIXCalibrator, Multi-Analyte Mixture
- BXXCalibrator, Pressure, Gas
- JITCalibrator, Secondary
- JGYColorimetric Method, Triglycerides
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- GKLCounter, Cell, Automated (Particle Counter)
- GKZCounter, Differential Cell
- GKKCyanomethemoglobin
- JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- JPIDevice, Hematocrit Measuring
- CIGDiazo Colorimetry, Bilirubin
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CGLElectrode, Ion Based, Enzymatic, Creatinine
- JJPElectrode, Ion Selective (Non-Specified)
- JFPElectrode, Ion Specific, Calcium
- CFAElectrode, Ion Specific, Magnesium
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CDSElectrode, Ion Specific, Urea Nitrogen
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- LFRGlucose Dehydrogenase, Glucose
- CGAGlucose Oxidase, Glucose
- JBJGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction
- GIGHemoglobinometer
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- GKFInstrument, Hematocrit, Automated
- LBRLdl & Vldl Precipitation, Hdl
- JPKMixture, Hematology Quality Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- GLYOximeter To Measure Hemoglobin
- GGZOxyhemoglobin
- JFLPh Rate Measurement, Carbon-Dioxide
- JGJPhotometric Method, Magnesium
- JEPRetainer, Matrix
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
- GFSStandards And Controls, Hemoglobin, Normal And Abnormal
- GKRSystem, Hemoglobin, Automated
- NBWSystem, Test, Blood Glucose, Over The Counter
- NGDTest, Lactic Acid, Over The Counter
- GJSTest, Time, Prothrombin
- JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
Showing 25 of 36| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0683-2025 | StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing | A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS. | Class I | Open, Classified | |
| Z-0682-2025 | StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing | A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS. | Class I | Open, Classified | |
| Z-0681-2025 | StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing. | A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment. | Class I | Open, Classified | |
| Z-0208-2024 | Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 63368 Stat Profile Prime Plus POC Analyzer (2) PN 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured P/N: 57400, 63368 | Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices. | Class II | Open, Classified | |
| Z-0207-2024 | Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured | Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices. | Class II | Open, Classified | |
| Z-2732-2017 | Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer | Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results. | Class II | Terminated | |
| Z-0650-2014 | Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole blood. | Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage | Class II | Terminated | |
| Z-1906-2013 | Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control | Reports of false abnormally high glucose readings from test strips | Class I | Terminated | |
| Z-1905-2013 | Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control | Reports of false abnormally high glucose readings from test strips | Class I | Terminated | |
| Z-1904-2013 | Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control | Reports of false abnormally high glucose readings from test strips | Class I | Terminated | |
| Z-1903-2013 | Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control | Reports of false abnormally high glucose readings from test strips | Class I | Terminated | |
| Z-1902-2013 | Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control | Reports of false abnormally high glucose readings from test strips | Class I | Terminated | |
| Z-1901-2013 | Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control | Reports of false abnormally high glucose readings from test strips | Class I | Terminated | |
| Z-1900-2013 | Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control | Reports of false abnormally high glucose readings from test strips | Class I | Terminated | |
| Z-1899-2013 | Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control | Reports of false abnormally high glucose readings from test strips | Class I | Terminated | |
| Z-1898-2013 | Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control | Reports of false abnormally high glucose readings from test strips | Class I | Terminated | |
| Z-1897-2013 | Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control | Reports of false abnormally high glucose readings from test strips | Class I | Terminated | |
| Z-1154-2013 | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only) | Glucose test strips reports no result message when tested | Class II | Terminated | |
| Z-1153-2013 | Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214 | Glucose test strips reports no result message when tested | Class II | Terminated | |
| Z-1783-2010 | Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454. Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial and neonate whole blood. | Glucose strips report low glucose results | Terminated | ||
| Z-1328-2009 | Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog # 35238 Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), reduced hemoglobin (HHb), Oxygen content (O2Ct) and Oxygen capacity (O2Cap) in heparinized whole blood; Na+, K+, CL-; Ca++, Mg++, Glucose heparinized whole blood, serum, or plasma. | Erroneous, low creatinine results on CCX analyzer | Terminated | ||
| Z-1472-2008 | Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and EZ CHEM Creatinine Meter (P/N 9600). Statstrip Meter an In vitro diagnostic for use by health care professionals in the quantitative determination of glucose (GLU) in whole blood. EZ Chem In vitro diagnostic for the quantitative measurement of creatinine in capillary, venous or arterial blood. | Lithium batteries may fail if the glucose or creatinine meters have been dropped. | Terminated | ||
| Z-0726-2008 | Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454 | Incorrect Results - Creatinine results were lower than the laboratory reference method. | Terminated | ||
| Z-0725-2008 | Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454 | Incorrect Results - Creatinine results were lower than the laboratory reference method. | Terminated | ||
| Z-0724-2008 | Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 P/N 9600, Nova Biomedical, Waltham, MA 02454 | Incorrect Results - Creatinine results were lower than the laboratory reference method. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain