Radiometer America, Inc
Middleburg Heights, OH, US
RADIOMETER AMERICA, INC. appears in FDA device records in Middleburg Heights, OH. FDA records list 50 510(k) clearances between and , 4 PMA records and 2 registered establishments. As of , FDA records show 64 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 50 510(k) clearances for Radiometer America, Inc between 1983 and 2016. The busiest year on record is 1995, with 8. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 2 |
| 1984 | 2 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1989 | 5 |
| 1990 | 4 |
| 1991 | 1 |
| 1992 | 5 |
| 1993 | 2 |
| 1994 | 5 |
| 1995 | 8 |
| 1996 | 5 |
| 1997 | 1 |
| 1998 | 3 |
| 1999 | 2 |
| 2000 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit | JJY | Substantially Equivalent | |
| K992859 | ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE | CHL | Substantially Equivalent | |
| K991417 | ABL 735 ANALYZER | CHL | Substantially Equivalent | |
| K982928 | NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM | CHL | Substantially Equivalent | |
| K980130 | ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM | CHL | Substantially Equivalent | |
| K980135 | QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 | JJS | Substantially Equivalent | |
| K974818 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | MMI | Substantially Equivalent | |
| K973367 | ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM | CHL | Substantially Equivalent | |
| K962158 | PICO MODELS 30, 50, 70 | JKA | Substantially Equivalent | |
| K962334 | EML105 ELECTROLYTE METABOLITE ANALYZER | JGS | Substantially Equivalent | |
| K961355 | MULTICHECK | JJS | Substantially Equivalent | |
| K961354 | QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) | JJS | Substantially Equivalent | |
| K952725 | MULTICHECK | GLY | Substantially Equivalent | |
| K954612 | ABL SYSTEM 625, 615, 605 | CHL | Substantially Equivalent | |
| K952621 | EML105 ELECTROLYTE METABOLITE ANALYZER | CGA | Substantially Equivalent | |
| K951241 | HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE | JWY | Substantially Equivalent | |
| K951240 | JUSTONE | JWY | Substantially Equivalent | |
| K952637 | QUALICHECK 4 GLUCOSE | JJS | Substantially Equivalent | |
| K936305 | SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | |
| K943882 | ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM | CHL | Substantially Equivalent | |
| K944753 | SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP | JWY | Substantially Equivalent | |
| K935655 | ABL5 BLOOD GAS SYSTEM | CHL | Substantially Equivalent | |
| K935121 | ABL SYSTEM 620 | CHL | Substantially Equivalent | |
| K935515 | MULTICHECK(TM) | JJS | Substantially Equivalent | |
| K935120 | EML 100 | JGS | Substantially Equivalent | |
| K935566 | SENSI-CAL AMCO AEPA-1 | LIE | Substantially Equivalent | |
| K924802 | CALIBRATION VERIFICATION KIT OR CVK | JJY | Substantially Equivalent | |
| K923045 | SENSITITRE SUSCEPTIBILITY PLATES | JWY | Substantially Equivalent | |
| K923342 | MICROBACT SOLID PLATE SYSTEMS | JJS | Substantially Equivalent | |
| K922922 | ABL50 BLOOD GAS SYSTEM | CHL | Substantially Equivalent | |
| K912444 | MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM | LGM | Substantially Equivalent | |
| K914166 | ABL505 BLOOD GAS & ELECTROLYTE SYSTEM | CHL | Substantially Equivalent | |
| K915399 | QUALICHECK 4 | JJS | Substantially Equivalent | |
| K910827 | ABL520 BLOOD GAS SYSTEM | GHS | Substantially Equivalent | |
| K904513 | ABL510 BLOOD GAS SYSTEM | CHL | Substantially Equivalent | |
| K904733 | QUALICHECK 3 | JJS | Substantially Equivalent | |
| K900333 | E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT. | LKD | Substantially Equivalent | |
| K896514 | QS90 SMOOTH E ARTERIAL BLOOD SAMPLER | GIM | Substantially Equivalent | |
| K895181 | ABL500 BLOOD GAS SYSTEM | CHL | Substantially Equivalent | |
| K893587 | OXIMETER | DQA | Substantially Equivalent | |
| K894776 | SENSITITRE INDOLE REAGENT | JSS | Substantially Equivalent | |
| K894110 | QUALICHECK 2 | JJS | Substantially Equivalent | |
| K890057 | SENSITITRE AUTO ID PLATE AP80 | LQM | Substantially Equivalent | |
| K871353 | OXIMETER | DQA | Substantially Equivalent | |
| K860057 | ABL330 ACID BASE LABORATORY | CHL | Substantially Equivalent | |
| K853990 | OSM3 HEMOXIMETER | JKS | Substantially Equivalent | |
| K844295 | ABL300 ACID BASE LABORATORY | CHL | Substantially Equivalent | |
| K833696 | ACID BASE LABORATORY ABL4 | CEM | Substantially Equivalent | |
| K831034 | QUALISTICK ARTERIAL BLOOD SAMPLER | CBT | Substantially Equivalent | |
| K830805 | KNAI SODIUM POTASSIUM ANALYZER | JSG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1523456 | 1523456 | RADIOMETER AMERICA, INC. | 6836 Engle Rd, Middleburg Heights, OH 44130 US | 2026 | |
| 3010420736 | 3010420736 | Radiometer America, Inc | 250 S Kraemer Blvd, Brea, CA 92821 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CBTArterial Blood Sampling Kit
- GHSAssay, Carboxyhemoglobin
- LGMChamber, Patient Isolation
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- JSGCulture Media, Non-Selective And Non-Differential
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGAGlucose Oxidase, Glucose
- LQMGram Negative Identification Panel
- MMIImmunoassay Method, Troponin Subunit
- JSSKit, Identification, Enterobacteriaceae
- JWYManual Antimicrobial Susceptibility Test Systems
- LKDMonitor, Carbon-Dioxide, Cutaneous
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DQAOximeter
- GLYOximeter To Measure Hemoglobin
- LIEReagent/Device, Inoculum Calibration
- JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
- GIMTubes, Vacuum Sample, With Anticoagulant
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
Recall records
Showing 25 of 64| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2320-2019 | ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 | Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment. | Class II | Terminated | |
| Z-0682-2019 | ABL800 analyzer, model numbers 393-800 and 393-801. | The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur. | Class II | Terminated | |
| Z-0801-2019 | Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845. | From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined on analyzers could be underestimated with up to 28% as compared with measurements from COBAS. The underestimated creatinine occurs specifically, when measurements on Autocheck 6+ level 1 (also known as S7835 Autocheck module and abbreviated AC6+L1) are less than or equal to 230 micro-meter of a specified insert interval for AC6+L1 with insert limits 210 290 micro-meter. Ultimately, a lower read-out on patient samples is observed Customers are concerned about underestimation of creatinine results in patients, which are to undergo radiocontrast x-ray investigations. If these patients are not healthy, the exposure of radiocontrast agents may induce kidney insufficiency (contrast-induced nephropathy). Hazardous situation: Underestimation of the concentration of creatinine. | Class II | Terminated | |
| Z-0010-2019 | ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting. | The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: The analyzer is in ready mode Operator lifts the inlet and then closes it again, thereby initiating a rinse Immediately after lifts the inlet and quickly closes it again | Class II | Terminated | |
| Z-0231-2018 | ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) - in vitro testing of samples of expired air for the parameters pO2 and pCO2. It is also used for in vitro testing of pleura samples for the pH parameter | Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer. | Class II | Terminated | |
| Z-3237-2017 | AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers | Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the control range. (4.92 5.85 kPa or 36.9 46.9 mmHg) " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg) | Class II | Terminated | |
| Z-1463-2017 | The ABL800 Model#:All | Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous. | Class II | Terminated | |
| Z-1462-2017 | ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood. | Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous. | Class II | Terminated | |
| Z-0899-2017 | AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use. | Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value. | Class II | Terminated | |
| Z-0748-2016 | AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers. | The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results. | Class II | Terminated | |
| Z-1595-2016 | TCM CombiM Modules 903-111 | Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume. | Class II | Terminated | |
| Z-2417-2015 | Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are used with the TCM CombiM monitoring system and the Philips TcG10 module. The TCM CombiM monitoring system is intended for continuous transcutaneous monitoring of carbon dioxide (tcpCO2) and oxygen (tcpO2) partial pressures. | When the fixation ring is taken off the paper liner there is a potential for fractions of the paper liner's surface coating to stick to the surface of the ring. | Class II | Terminated | |
| Z-1046-2015 | ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. | The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result. | Class II | Terminated | |
| Z-1293-2015 | Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2+,cCl-,cGlu, cLac, cCrea, ctBil, and co-oximetry parameters,(ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF), in vitro testing of samples of expired air for the parameters pO2 and pCO2, in vitro testing of pleura samples for the pH parameter. | Negative drift on QC during in-use lifetime of CREA membranes can be observed. | Class II | Terminated | |
| Z-0873-2015 | HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. Affected lots identified initially were 110705, 110706, 110715, 110716, 110717, 110718, 110719, and 110720. Subsequent investigation also identified as affected lots 1310227, 1310252, and 1310257. HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. | Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. after 6 months. The HemoCue Glucose 201 Analyzer with plasma conversion multiplies the measured whole blood glucose value by a factor of 1.11 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are for In Vitro Diag | Class II | Terminated | |
| Z-2597-2014 | RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data. | Class II | Terminated | ||
| Z-0816-2014 | ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. | RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results. | Class II | Terminated | |
| Z-1075-2014 | pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes. | RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results. | Class II | Terminated | |
| Z-0713-2014 | pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen). | RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner solution for pCO2 membrane units. This solution is a salt solution similar to the pO2 inner solution, but also contains glycerol which can be reduced at the cathode causing a suddenly rising zero current, causing the membrane unit to fail the following Cal2 calibration. | Class II | Terminated | |
| Z-1930-2013 | TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate. | RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B. | Class II | Terminated | |
| Z-2303-2013 | Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood. | RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane. | Class II | Terminated | |
| Z-2164-2012 | ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood. | A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t | Class II | Terminated | |
| Z-2163-2012 | The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. | A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t | Class II | Terminated | |
| Z-2162-2012 | The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. | A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t | Class II | Terminated | |
| Z-1008-2012 | S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark Product Usage: The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8x7 series creatine analyzers to establish calibration points for measured parameters. | When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10% of the solution to leak out when the bottle is placed horizontally for dissolving the additive. This will cause the concentration of creatinin and creatin in the calibration solution to be wrong, and results in a bias on the Crea results. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Radiometer America, Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain