Radiometer Medical Aps Akandevej 21 Bronshoj Denmark
This page shows every FDA and USDA recall linked to Radiometer Medical Aps Akandevej 21 Bronshoj Denmark. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
25
Total Recalls
2018
First Recall
2025
Most Recent
Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090
Radiometer ABL90 Series - Radiometer ABL...
Apr 23, 2025
· Device
Open, Classified
ABL800 FLEX
Model Numbers 393-800 and 393-801
The ABL800 FLEX analyzers are intended for:
" In Vitro testing...
Jul 24, 2024
· Device
Open, Classified
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 man...
Apr 17, 2023
· Device
Open, Classified
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
May 18, 2022
· Device
Open, Classified
Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for...
Apr 8, 2022
· Device
Open, Classified
Radiometer ABL90 FLEX Analyzer with E3800 PC units.
The E3800 CPU is also used as spare part.
Apr 14, 2021
· Device
Open, Classified
Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units.
The E3800 CPU is also used as spare part.
Apr 14, 2021
· Device
Open, Classified
E3800 PC Units (spare parts)
Apr 14, 2021
· Device
Open, Classified
PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sam...
Mar 26, 2021
· Device
Terminated
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. M...
May 26, 2020
· Device
Terminated
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. M...
May 26, 2020
· Device
Terminated
ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for u...
May 11, 2020
· Device
Terminated
ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended...
May 11, 2020
· Device
Terminated
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
Mar 17, 2020
· Device
Terminated
safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
Mar 17, 2020
· Device
Terminated
safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1
Mar 17, 2020
· Device
Terminated
ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH,...
Mar 10, 2020
· Device
Terminated
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Mar 6, 2020
· Device
Open, Classified
TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-...
Feb 20, 2020
· Device
Terminated
ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environ...
Feb 3, 2020
· Device
Terminated
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intende...
Feb 3, 2020
· Device
Terminated
ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are i...
Nov 21, 2019
· Device
Terminated
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: ar...
Nov 21, 2019
· Device
Terminated
AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999
Inte...
Aug 8, 2019
· Device
Terminated
AQURE, Software version 2.3.0 and 2.3.1
Product Usage:
The AQURE system is intended to let allow the manageme...
Mar 14, 2018
· Device
Terminated