Radiometer Medical ApS
21 recalls on record · Latest: Apr 30, 2025
FDA Devices Moderate Apr 30, 2025
Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 …
FDA Devices Moderate Jul 31, 2024
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the …
FDA Devices Moderate Apr 26, 2023
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 devices and opera…
FDA Devices Moderate May 25, 2022
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, …
FDA Devices Moderate Jun 23, 2021
E3800 PC Units (spare parts)
FDA Devices Moderate Jun 23, 2021
Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
FDA Devices Moderate Jun 23, 2021
Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
FDA Devices Moderate Jun 2, 2021
PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of art…
FDA Devices Moderate Jul 15, 2020
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the follow…
FDA Devices Moderate Jul 15, 2020
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. Th…
FDA Devices Moderate Jun 10, 2020
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
FDA Devices Moderate Jun 10, 2020
safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1
FDA Devices Moderate Jun 10, 2020
safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
FDA Devices Moderate Jun 3, 2020
ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologist…
FDA Devices Moderate Jun 3, 2020
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technolog…
FDA Devices Moderate Apr 29, 2020
ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care set…
FDA Devices Moderate Apr 29, 2020
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, …
FDA Devices Moderate Apr 29, 2020
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), TCM400 (902-5…
FDA Devices Moderate Apr 15, 2020
ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu…
FDA Devices Moderate Feb 5, 2020
AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intende…
FDA Devices Moderate May 9, 2018