Radiometer America Inc recalls Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: I

Recalled March 25, 2015 · FDA recall Z-1293-2015 · Radiometer America

Hazard

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

Units

10,824 boxes

Sold at

Worldwide Distribution - USA including NM, NC, TN, OH, NE, CA, MO, GA, MA, TX, WV, PA, NY, VA, MN, IN, ME, MD, IL, MI, KS, WI, FL, WA, CT, OK, CO, and Internationally to Canada, Denmark, Spain, Italy, India, Sweden, Germany, Australia, Hungary, Great Britain, Norway, Uruguay, France, Poland, Switerland, Russian Federation, Netherlands, Czech Republic, Mexico, Brazil, Czechoslovakia, Austria, Singapore, Syria, Phillipines, Egypt, Bolivia, Japan, New Zealand, Turkey, Saudi Arabia, Algeria, Qatar, and Finland.

Description

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

Product

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 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.

Manufacturer(s)

Radiometer America Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →