Radiometer Medical Aps
Medical device manufacturer in Bronshoj, Denm.
28510(k) clearances
0PMA approvals
25recalls
Device types
- CHL Electrode Measurement, Blood-Gases (Pco2… 13
- JJS Controls For Blood-Gases, (Assayed And… 3
- LKD Monitor, Carbon-Dioxide, Cutaneous 2
- JHX Fluorometric Method, Cpk Or Isoenzymes 2
- MQM Bilirubin (Total And Unbound) In The… 2
- JKA Tubes, Vials, Systems, Serum Separators… 1
- CIG Diazo Colorimetry, Bilirubin 1
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- CGL Electrode, Ion Based, Enzymatic, Creatinine 1
- CEM Electrode, Ion Specific, Potassium 1
- KHO Fluorometer, For Clinical Use 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXJHX · Traditional | 09/21/2017SE |
| K170882 | ABL90 Flex, ABL90 Flex PlusMQM · Traditional | 04/28/2017SE |
| K160153 | ABL90 Flex PlusCHL · Special | 11/04/2016SE |
| K142898 | ABL800 FLEX with AQURE connectivityCHL · Special | 06/17/2015SE |
| K150226 | Hematocrit and Metabolite QUALICHECKJJS · Traditional | 05/13/2015SE |
| K132691 | ABL90 FlexMQM · Traditional | 11/13/2014SE |
| K131988 | ABL90 Flex AnalyzerCHL · Traditional | 09/17/2013SE |
| K130144 | ABL90 FlexCHL · Special | 07/31/2013SE |
| K123748 | ABL90 FlexCHL · Special | 05/07/2013SE |
| K130415 | High Metabolite QualicheckJJS · Traditional | 03/26/2013SE |
| K130236 | Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3JJS · Traditional | 03/15/2013SE |
| K120326 | AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal…JHX · Traditional | 11/21/2012SE |
| K122729 | ABL90 FlexCHL · Special | 11/16/2012SE |
| K122642 | ABL90 FlexCHL · Special | 10/26/2012SE |
| K120197 | ABL90 FlexCHL · Special | 03/19/2012SE |
| K112161 | AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS…KHO · Traditional | 01/20/2012SE |
| K111897 | ABL90CHL · Special | 07/19/2011SE |
| K110416 | ABL835 Flex Analyzer with Pleural PHCHL · Traditional | 03/24/2011SE |
| K100777 | ABL837 Flex AnalyzerCHL · Abbreviated | 12/10/2010SE |
| K092686 | ABL90 Flex SeriesCEM · Traditional | 08/06/2010SE |
| K093154 | TCM Tosca Monitoring System, TCM Combim Monitoring SystemLKD · Traditional | 02/05/2010SE |
| K051968 | ABL8X7 FlexCGL · Traditional | 10/16/2006SE |
| K051928 | AUTOCHECK6+JJY · Traditional | 10/12/2005SE |
| K050869 | Modification to ABL800 FlexCIG · Special | 08/11/2005SE |
| K043218 | ABL800 Flex with Flexq Module, Model ABL8XXCHL · Traditional | 05/10/2005SE |
| K043143 | SafepicoJKA · Traditional | 04/22/2005SE |
| K043003 | TCM40 Monitoring SystemLKD · Abbreviated | 03/01/2005SE |
| K041874 | ABL800 FlexCHL · Traditional | 10/08/2004SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1659-2025 Class II | Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90…ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10… | 03/21/2025Open, Classified |
| Z-2426-2024 Class II | ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended…Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially… | 05/31/2024Open, Classified |
| Z-1394-2023 Class II | AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is…Due to potential software issue that may result in patient mix-up information. | 03/08/2023Open, Classified |
| Z-1321-2022 Class II | ABL800 Flex Analyzer Model Numbers 393-800 and 393-801There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured… | 05/18/2022Open, Classified |
| Z-1115-2022 Class II | Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU…Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product. | 04/08/2022Open, Classified |
| Z-1858-2021 Class II | E3800 PC Units (spare parts)Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | 04/14/2021Open, Classified |
| Z-1857-2021 Class II | Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as…Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | 04/14/2021Open, Classified |
| Z-1856-2021 Class II | Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare…Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | 04/14/2021Open, Classified |
| Z-1683-2021 Class II | PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized…Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile… | 03/26/2021Terminated |
| Z-2494-2020 Class II | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI…Potential risk of patient mix-up on analyzers due to software issues. | 05/26/2020Terminated |
| Z-2493-2020 Class II | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI…Potential risk of patient mix-up on analyzers due to software issues. | 05/26/2020Terminated |
| Z-2468-2020 Class II | ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product…Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose… | 05/11/2020Terminated |
| Z-2467-2020 Class II | ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage:…Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose… | 05/11/2020Terminated |
| Z-2249-2020 Class II | safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost… | 03/17/2020Terminated |
| Z-2248-2020 Class II | safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost… | 03/17/2020Terminated |
| Z-2247-2020 Class II | safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost… | 03/17/2020Terminated |
| Z-1684-2020 Class II | ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood…Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or… | 03/10/2020Terminated |
| Z-1836-2020 Class II | ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004Through internal investigation is has been determined that an incorrect component was used within the power… | 03/06/2020Open, Classified |
| Z-1755-2020 Class II | TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4…Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming… | 02/20/2020Terminated |
| Z-1761-2020 Class II | ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use…The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally… | 02/03/2020Terminated |
| Z-1760-2020 Class II | ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 -…The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally… | 02/03/2020Terminated |
| Z-2139-2020 Class II | ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 -…The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the… | 11/21/2019Terminated |
| Z-2138-2020 Class II | ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 -…The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the… | 11/21/2019Terminated |
| Z-0864-2020 Class II | AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI:…The firm has become aware that there is a potential problem relating to the blood gas and immunoassay… | 08/08/2019Terminated |
| Z-1582-2018 Class II | AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to…There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in… | 02/27/2018Terminated |