Recall Z-1906-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Bio-Rad Laboratories, Inc
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
| Date | Jan 10, 2019 |
| Status | Open, Classified |
| Reason | User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneous results to the customer's Laboratory Information System (LIS). |
| Root cause | Software design |
| Action | The recalling firm issued letters dated 1/9/2019 via FedEx on 1/10/2019 to all EVOLIS customers. |
| Quantity | 213 devices |
| Distribution | Distribution was nationwide to medical facilities, including to Puerto Rico. There was also government/military distribution. There was no foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.