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Radiometer Medical ApS

FDA Regulatory Profile

Summary

Total Recalls
25
510(k) Clearances
28
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1659-2025Class IIRadiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - RaMarch 21, 2025
Z-2426-2024Class IIABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " InMay 31, 2024
Z-1394-2023Class IIAQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intendMarch 8, 2023
Z-1321-2022Class IIABL800 Flex Analyzer Model Numbers 393-800 and 393-801May 18, 2022
Z-1115-2022Class IIRadiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparinApril 8, 2022
Z-1856-2021Class IIRadiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.April 14, 2021
Z-1858-2021Class IIE3800 PC Units (spare parts)April 14, 2021
Z-1857-2021Class IIRadiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare partApril 14, 2021
Z-1683-2021Class IIPIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterialMarch 26, 2021
Z-2493-2020Class IIBlood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)0570069May 26, 2020
Z-2494-2020Class IIBlood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)0570069May 26, 2020
Z-2468-2020Class IIABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It iMay 11, 2020
Z-2467-2020Class IIABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is inteMay 11, 2020
Z-2248-2020Class IIsafeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1March 17, 2020
Z-2247-2020Class IIsafeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1March 17, 2020
Z-2249-2020Class IIsafeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1March 17, 2020
Z-1684-2020Class IIABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the paramMarch 10, 2020
Z-1836-2020Class IIABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004March 6, 2020
Z-1755-2020Class IITCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TFebruary 20, 2020
Z-1760-2020Class IIABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It February 3, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXSeptember 21, 2017
K170882ABL90 FLEX, ABL90 FLEX PLUSApril 28, 2017
K160153ABL90 FLEX PLUSNovember 4, 2016
K142898ABL800 FLEX with AQURE connectivityJune 17, 2015
K150226Hematocrit and Metabolite QUALICHECKMay 13, 2015
K132691ABL90 FLEXNovember 13, 2014
K131988ABL90 FLEX ANALYZERSeptember 17, 2013
K130144ABL90 FLEXJuly 31, 2013
K123748ABL90 FLEXMay 7, 2013
K130415HIGH METABOLITE QUALICHECKMarch 26, 2013
K130236RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3March 15, 2013
K120326AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGENovember 21, 2012
K122729ABL90 FLEXNovember 16, 2012
K122642ABL90 FLEXOctober 26, 2012
K120197ABL90 FLEXMarch 19, 2012
K112161AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEXJanuary 20, 2012
K111897ABL90July 19, 2011
K110416ABL835 FLEX ANALYZER WITH PLEURAL PHMarch 24, 2011
K100777ABL837 FLEX ANALYZERDecember 10, 2010
K092686ABL90 FLEX SERIESAugust 6, 2010