Reported Mar 5, 2014 · Terminated
pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument…
Radiometer America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Radiometer America Inc · 810 Sharon Dr · Westlake, OH · 44145-1521
Is this the product you have?
- 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.
- Lot codes and dates
- Model #: 942-063 Lot #'s: R338 to R493
- Amount recalled
- 38,890 units (7,860 units imported into the US)
Where it was sold
Why it was recalled
RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.
This product could cause temporary or reversible health problems — stop using it.
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