FDA-Device2014-03-05Class II
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.
Radiometer America Inc
Hazard
RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.
Sold states
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.
Affected count
38,890 units (7,860 units imported into the US)
Manufactured in
810 Sharon Dr, Westlake, OH, United States
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 whole blood using multiple special electrodes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1075-2014Don't want to check this manually?
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