AUTION HYBRID AU-4050

Reason: 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.

Code information: UDI: (01) 00015482146030 All serial numbers

Distribution pattern: US