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