Recall Z-1906-2019— Bio-Rad Laboratories, Inc
Class II · Ongoing
Class II FDA medical device recall by Bio-Rad Laboratories, Inc, initiated 2019-01-10. FDA's recall record names no specific 510(k) clearance for this event. Product: EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.. 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)..
- Recalling firm
- Bio-Rad Laboratories, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-01-10
- Firm location
- Redmond, WA, United States
Product description
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Reason for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.