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.
FDA Recall Z-1075-2014 · Posted 2014-02-24
Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2013-07-05
Date Terminated2015-09-19
Product Quantity38,890 units (7,860 units imported into the US)
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.
Firm Action
On 7/18/2013, the firm sent Product Notification letters to their customers.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.