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Recall Observatory FDA recall evidence

Device 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.

Z-1075-2014

July 05, 2013

Class II

Product summary

Firm
Radiometer America Inc
Event
Event 67066
Status
Terminated
Classification
Class II
Quantity
38,890 units (7,860 units imported into the US)
Official record key
device-enforcement:Z-1075-2014

Official wording

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

Code information: Model #: 942-063 Lot #'s: R338 to R493

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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