Recall Z-0231-2018— Radiometer America Inc

Name: FDA recall Z-0231-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-24

Class II · Terminated

Class II FDA medical device recall by Radiometer America Inc, initiated 2017-10-24, terminated 2023-10-10. It names one FDA 510(k) clearance: K041874. Product: ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters 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. It is also used for in vitro testing of pleura samples for the pH parameter. Reason: Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer..

Recalling firm: Radiometer America Inc
Classification: Class II
Status: Terminated
Initiated: 2017-10-24
Terminated: 2023-10-10
Firm location: Brea, CA, United States

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 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters 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. It is also used for in vitro testing of pleura samples for the pH parameter

Reason for recall

Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.

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