FDAOctober 29, 2014device

Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are 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 fracti...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Negative drift on QC during in-use lifetime of CREA membranes can be observed.

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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