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Radiometer Medical ApS FDA Recalls
9 recalls on file across devices, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX Class IIMar 21, 2025ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiom |
| ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of saClass IIMay 31, 2024Issue with analyzer when the pH of the calibration solution |
| 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 manageClass IIMar 8, 2023Due to potential software issue that may result in patient m |
| ABL800 Flex Analyzer Model Numbers 393-800 and 393-801Class IIMay 18, 2022There is a potential for sporadic incidents of positive and |
| Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection.Class IIApr 8, 2022Arterial Blood Sampler sterility cannot be guaranteed throu |
| E3800 PC Units (spare parts)Class IIApr 14, 2021Due to an issue with the internal clock of the analyzers wit |
| Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.Class IIApr 14, 2021Due to an issue with the internal clock of the analyzers wit |
| Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.Class IIApr 14, 2021Due to an issue with the internal clock of the analyzers wit |
| PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler produClass IIMar 26, 2021Radiometer has become aware of an issue with PICO70 Arterial |