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.

This recall has been terminated (originally issued February 24, 2014).

Company: Radiometer America Inc
Recall Initiated: July 5, 2013
Posted: February 24, 2014
Terminated: September 19, 2015
Recall Number: Z-1075-2014
Quantity: 38,890 units (7,860 units imported into the US)
Firm Location: Westlake, OH
Official Source: View on FDA website ↗

Reason for Recall

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

Distribution

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.