Radiometer Medical ApS: 12 recalls on record

Recalls filed with 1 agency: FDA (12).

First recall on record: May 9, 2018. Most recent: July 31, 2024.

Risk classification: Class II: 12

Most recent recalls

DateAgencyProduct
July 31, 2024FDAABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended …Z-2426-2024
April 26, 2023FDAAQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE syste…Z-1394-2023
May 25, 2022FDARadiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balan…Z-1115-2022
July 15, 2020FDABlood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI …Z-2493-2020
July 15, 2020FDABlood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI …Z-2494-2020
June 10, 2020FDAsafeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1Z-2249-2020
June 10, 2020FDAsafeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1Z-2248-2020
June 3, 2020FDAABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 -…Z-2139-2020
April 29, 2020FDAABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in…Z-1761-2020
April 29, 2020FDAABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product…Z-1760-2020
February 5, 2020FDAAQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01…Z-0864-2020
May 9, 2018FDAAQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended t…Z-1582-2018

Questions about this company

How many recalls does Radiometer Medical ApS have?
Recalert has 12 U.S. recalls on record for Radiometer Medical ApS, published between May 9, 2018 and July 31, 2024.
What was the most recent Radiometer Medical ApS recall?
FDA recall Z-2426-2024, published July 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 parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , …
Which agencies have handled Radiometer Medical ApS recalls?
Radiometer Medical ApS appears as the recalling firm in recalls from: FDA (12).

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