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Radiometer Medical Aps Recalls

18 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Radiometer Medical Aps.

18Total Recalls
0Critical
418,352Units Affected
May 31, 2024Most Recent
All Recalls

Every Radiometer Medical Aps Recall

Sorted by most recent. Click any recall for full details.

18 recalls
High RiskFDA
Radiometer Medical Aps
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole bl...
Medical Devices·27,127 affected·May 31, 2024
High RiskFDA
Radiometer Medical Aps
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 analytical devic...
Medical Devices·1,806 affected·Mar 8, 2023
High RiskFDA
Radiometer Medical Aps
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, ...
Medical Devices·7,228 affected·Apr 8, 2022
High RiskFDA
Radiometer Medical Aps
E3800 PC Units (spare parts)
Medical Devices·965 affected·Apr 14, 2021
High RiskFDA
Radiometer Medical Aps
Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Medical Devices·3,346 affected·Apr 14, 2021
High RiskFDA
Radiometer Medical Aps
PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for colle...
Medical Devices·348,178 affected·Mar 26, 2021
High RiskFDA
Radiometer Medical Aps
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available i...
Medical Devices·4,615 affected·May 26, 2020
High RiskFDA
Radiometer Medical Aps
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available a...
Medical Devices·3,899 affected·May 26, 2020
High RiskFDA
Radiometer Medical Aps
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
Medical Devices·269 affected·Mar 17, 2020
High RiskFDA
Radiometer Medical Aps
safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1
Medical Devices·5 affected·Mar 17, 2020
High RiskFDA
Radiometer Medical Aps
safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
Medical Devices·1,314 affected·Mar 17, 2020
High RiskFDA
Radiometer Medical Aps
TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), T...
Medical Devices·84 affected·Feb 20, 2020
High RiskFDA
Radiometer Medical Aps
ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point...
Medical Devices·3,968 affected·Feb 3, 2020
High RiskFDA
Radiometer Medical Aps
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory e...
Medical Devices·12,822 affected·Feb 3, 2020
High RiskFDA
Radiometer Medical Aps
ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained ...
Medical Devices·1,233 affected·Nov 21, 2019
High RiskFDA
Radiometer Medical Aps
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by train...
Medical Devices·544 affected·Nov 21, 2019
High RiskFDA
Radiometer Medical Aps
AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE syste...
Medical Devices·947 affected·Aug 8, 2019
High RiskFDA
Radiometer Medical Aps
AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices...
Medical Devices·2 affected·Feb 27, 2018