FDAOctober 24, 2017device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
radiometer americaradiometer
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDADigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.2026-05-01
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