Recall Z-1684-2020— Radiometer Medical ApS

Name: FDA recall Z-1684-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-10

Class II · Terminated

Class II FDA medical device recall by Radiometer Medical ApS, initiated 2020-03-10, terminated 2022-10-31. It names one FDA 510(k) clearance: K041874. 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 - Product Usage:. 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: Radiometer Medical ApS
Classification: Class II
Status: Terminated
Initiated: 2020-03-10
Terminated: 2022-10-31
Firm location: Bronshoj, N/A, Denmark

510(k) clearances named in this recall

1 on FDA's record

K041874 — ABL800 FLEXRadiometer Medical Aps·cleared 2004-10-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 - Product Usage:

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.