Reported Feb 10, 2016 · Terminated
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
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 · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- AQURE System
- Model Number933-599. The AQURE System manages blood gas and immunoassay analyzers
- Lot codes and dates
- Model Number933-599 Version 1.8.3
- Amount recalled
- 375
Where it was sold
Why it was recalled
The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.
This product could cause temporary or reversible health problems — stop using it.
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