Reported Jun 26, 2019 · Terminated
AUTION HYBRID AU-4050
Arkray Factory USA, 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: Arkray Factory USA, Inc. · 5182 W 76th St · Minneapolis, MN · 55439-2900
Is this the product you have?
- AUTION HYBRID AU-4050
- Lot codes and dates
- UDI(01) 00015482146030 All serial numbers
- Amount recalled
- 159 units
Why it was recalled
This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due to an error by a urine sediment measurement. 2) The instrument is shutdown incorrectly. 3) An item rack is used for subsequent sample measurements.
This product could cause temporary or reversible health problems — stop using it.
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