Recall Z-1850-2019
Arkray Factory USA, Inc. · initiated May 3, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AUTION HYBRID AU-4050
Codes / lots: UDI: (01) 00015482146030 All serial numbers
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.
FDA-determined cause: Software design
Action taken
The firm initiated the field correction by email on 05/03/2019. The letter stated how to recognize a product failure and the actions to be taking by the customer until the software upgrade is ready for installation.
Details
- Recall number
- Z-1850-2019
- Initiated
- May 3, 2019
- Terminated
- September 17, 2020
- Product code
- KQO – Automated Urinalysis System
- Quantity
- 159 units
- Distribution
- US
- Recalling firm
- Arkray Factory USA, Inc., Minneapolis, MN