Reported Jan 22, 2014 · Terminated
pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering…
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?
- pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).
- Lot codes and dates
Part #: 942-042Lot #: R0971
- Amount recalled
- 209 boxes/6 membranes
Where it was sold
Why it was recalled
RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner solution for pCO2 membrane units. This solution is a salt solution similar to the pO2 inner solution, but also contains glycerol which can be reduced at the cathode causing a suddenly rising zero current, causing the membrane unit to fail the following Cal2 calibration.
This product could cause temporary or reversible health problems — stop using it.
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