Company: Radiometer Medical ApS
Date of Enforcement Report: 7/15/2020
Class II
PRODUCT
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 following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module is optional and can be added to all models and configurations.
Recall Number: Z-2493-2020
REASON
Potential risk of patient mix-up on analyzers due to software issues.
RECALLING FIRM/MANUFACTURER
Radiometer Medical ApS on 5/26/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4,615 units
DISTRIBUTION
U.S. Nationwide and International