Company:Radiometer America
Date of Enforcement Report 12/20/2017
Class lI:
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
Recall Number Z-0231-2018
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/MANUFACTURER
Radiometer America, Brea, CA on 10/24/2017. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
1,749 analyze
DISTRIBUTION
Nationwide and Canada
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