Radiometer Medical ApS
Complete recall history across all FDA and CPSC categories — 25 total recalls
Radiometer Medical ApS appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (25)
FDA medical device enforcement actions by Radiometer Medical ApS
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 21, 2025 | Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radio... | ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 v... | Class II |
| May 31, 2024 | ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers a... | Issue with analyzer when the pH of the calibration solution decreases during ... | Class II |
| Mar 8, 2023 | AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The... | Due to potential software issue that may result in patient mix-up information. | Class II |
| May 18, 2022 | ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 | There is a potential for sporadic incidents of positive and negative biases f... | Class II |
| Apr 8, 2022 | Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU elect... | Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf l... | Class II |
| Apr 14, 2021 | Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is ... | Due to an issue with the internal clock of the analyzers with an e3800 PC uni... | Class II |
| Apr 14, 2021 | Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also ... | Due to an issue with the internal clock of the analyzers with an e3800 PC uni... | Class II |
| Apr 14, 2021 | E3800 PC Units (spare parts) | Due to an issue with the internal clock of the analyzers with an e3800 PC uni... | Class II |
| Mar 26, 2021 | PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electro... | Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. T... | Class II |
| May 26, 2020 | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 3... | Potential risk of patient mix-up on analyzers due to software issues. | Class II |
| May 26, 2020 | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 3... | Potential risk of patient mix-up on analyzers due to software issues. | Class II |
| May 11, 2020 | ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Pr... | Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood g... | Class II |
| May 11, 2020 | ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 0570069393841... | Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood g... | Class II |
| Mar 17, 2020 | safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1 | The SafeCLINITUBES blood sampler may have insufficient aspiration capabilitie... | Class II |
| Mar 17, 2020 | safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1 | The SafeCLINITUBES blood sampler may have insufficient aspiration capabilitie... | Class II |
| Mar 17, 2020 | safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1 | The SafeCLINITUBES blood sampler may have insufficient aspiration capabilitie... | Class II |
| Mar 10, 2020 | ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of wh... | Analyzer's barcode reader misinterprets the contents of barcode label used f... | Class II |
| Mar 6, 2020 | ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 | Through internal investigation is has been determined that an incorrect compo... | Class II |
| Feb 20, 2020 | TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor mo... | Reports have been received about the transcutaneous monitoring system display... | Class II |
| Feb 3, 2020 | ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4M... | The firm received reports of occurrences where the barcode reader misinterpr... | Class II |
| Feb 3, 2020 | ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intende... | The firm received reports of occurrences where the barcode reader misinterpr... | Class II |
| Nov 21, 2019 | ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): ... | The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cu... | Class II |
| Nov 21, 2019 | ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R052... | The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cu... | Class II |
| Aug 8, 2019 | AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx On... | The firm has become aware that there is a potential problem relating to the b... | Class II |
| Feb 27, 2018 | AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system i... | There is a potential problem relating to the AQURE System, versions 2.3.0 and... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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