Z-1850-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2019
- Initiation Date
- May 3, 2019
- Termination Date
- September 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 159 units
Product Description
AUTION HYBRID AU-4050
Reason for Recall
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.
Distribution Pattern
US
Code Information
UDI: (01) 00015482146030 All serial numbers