Radiometer Medical ApS
FDA Regulatory Profile
Radiometer Medical ApS appears in FDA public data with 25 recalls, 28 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1659-2025, Class II) was initiated on March 21, 2025. Its most recent 510(k) clearance was granted on September 21, 2017.
Summary
- Total Recalls
- 25
- 510(k) Clearances
- 28
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1659-2025 | Class II | Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Ra | March 21, 2025 |
| Z-2426-2024 | Class II | ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In | May 31, 2024 |
| 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 intend | March 8, 2023 |
| Z-1321-2022 | Class II | ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 | May 18, 2022 |
| Z-1115-2022 | Class II | Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin | April 8, 2022 |
| Z-1858-2021 | Class II | E3800 PC Units (spare parts) | April 14, 2021 |
| Z-1856-2021 | Class II | Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part. | April 14, 2021 |
| Z-1857-2021 | Class II | Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part | April 14, 2021 |
| Z-1683-2021 | Class II | PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial | March 26, 2021 |
| Z-2493-2020 | Class II | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)0570069 | May 26, 2020 |
| Z-2494-2020 | Class II | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)0570069 | May 26, 2020 |
| Z-2467-2020 | Class II | ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is inte | May 11, 2020 |
| Z-2468-2020 | Class II | ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It i | May 11, 2020 |
| Z-2248-2020 | Class II | safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1 | March 17, 2020 |
| Z-2249-2020 | Class II | safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1 | March 17, 2020 |
| Z-2247-2020 | Class II | safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1 | March 17, 2020 |
| Z-1684-2020 | Class II | ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the param | March 10, 2020 |
| Z-1836-2020 | Class II | ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 | March 6, 2020 |
| Z-1755-2020 | Class II | TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), T | February 20, 2020 |
| Z-1760-2020 | Class II | ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It | February 3, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX | September 21, 2017 |
| K170882 | ABL90 FLEX, ABL90 FLEX PLUS | April 28, 2017 |
| K160153 | ABL90 FLEX PLUS | November 4, 2016 |
| K142898 | ABL800 FLEX with AQURE connectivity | June 17, 2015 |
| K150226 | Hematocrit and Metabolite QUALICHECK | May 13, 2015 |
| K132691 | ABL90 FLEX | November 13, 2014 |
| K131988 | ABL90 FLEX ANALYZER | September 17, 2013 |
| K130144 | ABL90 FLEX | July 31, 2013 |
| K123748 | ABL90 FLEX | May 7, 2013 |
| K130415 | HIGH METABOLITE QUALICHECK | March 26, 2013 |
| K130236 | RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 | March 15, 2013 |
| K120326 | AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE | November 21, 2012 |
| K122729 | ABL90 FLEX | November 16, 2012 |
| K122642 | ABL90 FLEX | October 26, 2012 |
| K120197 | ABL90 FLEX | March 19, 2012 |
| K112161 | AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX | January 20, 2012 |
| K111897 | ABL90 | July 19, 2011 |
| K110416 | ABL835 FLEX ANALYZER WITH PLEURAL PH | March 24, 2011 |
| K100777 | ABL837 FLEX ANALYZER | December 10, 2010 |
| K092686 | ABL90 FLEX SERIES | August 6, 2010 |