FDA Device

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.

Hazard

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

What You Should Do

Remedy

On 7/18/2013, the firm sent Product Notification letters to their customers.

Products

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 w
Brand
Radiometer America Inc
UPC
Model #: 942-063 Lot #'s: R338 to R493

Units Affected

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