Radiometer America Inc recalls pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument

Recalled March 5, 2014 · FDA recall Z-1075-2014 · Radiometer America

Hazard

RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results. · FDA Class II

Units

38,890 units (7,860 units imported into the US)

Sold at

Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY, and the countries of Bermuda and Canada.

Description

RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.

Product

pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.

Manufacturer(s)

Radiometer America Inc

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