Company: Radiometer Medical ApS
Date of Enforcement Report: 4/15/2020
Class II

PRODUCT

ABL800 FLEX, model number/UDI 393-800/0570

• In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF).
• In vitro testing of samples of expired air for the parameters pO2 and pCO2 In vitro testing of pleura samples for the pH parameter.0693938004 and 393-801/05700693938011.

Recall Number: Z-1684-2020

REASON

Analyzer’s barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss of sample resulting in delayed medical treatment

RECALLING FIRM/MANUFACTURER

Radiometer Medical ApS on 3/10/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

3,656 units

DISTRIBUTION

US Nationwide and International