Recall Z-1850-2019 ยท KQO Automated Urinalysis System
Arkray Factory USA, Inc.
AUTION HYBRID AU-4050
| Date | May 3, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 159 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121456 | AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL Arkray, Inc., Feb 1, 2013 |