Radiometer Medical ApS recalls
Every recall we track for Radiometer Medical ApS — 26 in all, from 2018–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Radiometer Medical ApS peaked in 2020 (12); 26 since 2017.
All FDA recall records for Radiometer Medical ApS since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 1 | 0 | 1 |
| 2019 | 0 | 1 | 2 | 0 | 3 |
| 2020 | 0 | 7 | 5 | 0 | 12 |
| 2021 | 0 | 0 | 4 | 0 | 4 |
| 2022 | 0 | 0 | 2 | 0 | 2 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
Most common reasons for Radiometer Medical ApS recalls
What to do if you have a recalled Radiometer Medical ApS product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Radiometer Medical ApS recalls
18 shown- Lower riskMedical device
Radiometer Medical ApS recalls The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and
Radiometer recalls ABL90 FLEX analyzers with software versions 3.6 or lower that may produce inaccurate blood test results. Affected units were sold nationwide in the US from 2026.
RadiometerAug 18, 2026 - Lower riskMedical device
Radiometer Medical ApS recalls Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX
Radiometer ABL90 FLEX analyzers with Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze during sample measurements, causing test delays. Affected units include specific model numbers and serials listed in the recall.
RadiometerMar 21, 2025 - Lower riskMedical device
Radiometer Medical ApS recalls ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples
Radiometer recalls ABL800 FLEX analyzers with model numbers 393-800 and 393-801 due to potential pH bias from bacterial growth in calibration solutions. Users should check their device model and contact Radiometer for remediation.
RadiometerMay 31, 2024 - Lower riskMedical device
Radiometer Medical ApS recalls 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 intended to let you manage
Radiometer recalls AQURE REF 933-599 software versions 2.5.2 through 2.6.1 due to potential patient information mix-ups. Affected medical devices may require software updates to prevent errors in patient data management.
RadiometerMar 8, 2023 - Lower riskMedical device
Radiometer Medical ApS recalls ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Radiometer recalls specific ABL800 Flex analyzers with software versions below V6.19 MR2 due to potential bias in blood test results for certain analytes.
RadiometerMay 18, 2022 - Lower riskMedical device
Radiometer Medical ApS recalls Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for
Radiometer recalls arterial blood samplers due to potential sterility issues. All units sold may be affected. Consumers should contact Radiometer for details.
RadiometerApr 8, 2022 - Lower riskMedical device
Radiometer Medical ApS recalls E3800 PC Units (spare parts)
Radiometer recalls spare E3800 PC units (part 910-414) due to internal clock malfunction. Affected units may display incorrect results. Contact Radiometer for replacement.
RadiometerApr 14, 2021 - Lower riskMedical device
Radiometer Medical ApS recalls PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler
Radiometer recalls PICO70 arterial blood samplers due to a remote risk of bacterial bloodstream infection, especially for immunosuppressed patients. The issue involves potential breaches in the sterile barrier system.
RadiometerMar 26, 2021 - Use cautionMedical device
Radiometer Medical ApS recalls Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model
Radiometer recalls ABL800 FLEX blood gas test systems with software versions 6.19 and below due to potential patient mix-up risks. Affected units have specific model numbers and UDI codes.
RadiometerMay 26, 2020 - Use cautionMedical device
Radiometer Medical ApS recalls ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use
Radiometer recalls ABL80-FLEX CO-OX 393-841 lab equipment due to barcode misreads causing patient mix-ups or delayed treatment. All units affected.
RadiometerMay 11, 2020 - Lower riskMedical device
Radiometer Medical ApS recalls safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
Radiometer recalls SafeCLINITUBES blood samplers with lot numbers R1431-R1495 due to possible insufficient aspiration causing lost samples. Consumers should check their lot numbers.
RadiometerMar 17, 2020 - Use cautionMedical device
Radiometer Medical ApS recalls ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2,
Radiometer recalls ABL800 FLEX blood analyzers with model 393-800/0570 that may mix up patient samples due to barcode errors, risking delayed treatment.
RadiometerMar 10, 2020 - Use cautionMedical device
Radiometer Medical ApS recalls ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Radiometer recalls ABL800 FLEX models 393-800 and 393-801 with UDI (01)05700693938004 due to a power supply defect that could delay critical treatment. Affected units have specific serial numbers.
RadiometerMar 6, 2020 - Use cautionMedical device
Radiometer Medical ApS recalls TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778,
Radiometer recalls TCM4 Base units with specific serial numbers due to display flickering and monitor unresponsiveness, which could delay patient monitoring and compromise product performance.
RadiometerFeb 20, 2020 - Lower riskMedical device
Radiometer Medical ApS recalls ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment,
Radiometer recalls ABL90 FLEX PLUS analyzers with software below 3.4 MR2 due to barcode misreads causing patient mixups and sample loss. Affected units may delay medical treatment.
RadiometerFeb 3, 2020 - Lower riskMedical device
Radiometer Medical ApS recalls ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended
Radiometer recalls ABL90 FLEX blood analyzers and spare hemolyzer units due to potential measurement errors in blood tests. Affected units may provide inaccurate results for certain blood measurements.
RadiometerNov 21, 2019 - Use cautionMedical device
Radiometer Medical ApS recalls AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use:
Radiometer recalls AQURE basic system (version 2.3.3) due to potential patient data mix-up with third-party devices, risking serious health consequences. Affected units have specific UDI codes.
RadiometerAug 8, 2019 - Lower riskMedical device
Radiometer Medical ApS recalls AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of
Radiometer recalls AQURE software versions 2.3.0 and 2.3.1 due to potential patient mix-up. Affected healthcare facilities should update software to prevent misidentification of patient data.
RadiometerFeb 27, 2018
Radiometer Medical ApS recall questions
How many recalls has Radiometer Medical ApS had?
26 recalls from Radiometer Medical ApS are on record with U.S. safety agencies, from 2018–2026.
What is the most recent Radiometer Medical ApS recall?
Radiometer Medical ApS recalls The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and, dated Aug 18, 2026. Every Radiometer Medical ApS recall is listed on this page, newest first.
Why are Radiometer Medical ApS products recalled?
The most common reasons on record: Potential risk of patient mix-up on analyzers due to software issues. (2).
What should I do if I have a recalled Radiometer Medical ApS product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Radiometer Medical ApS recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.