Recall Z-1906-2019
Bio-Rad Laboratories, Inc · initiated January 10, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Codes / lots: Software version 1.4, UDI for the software is 03610520562024.
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).
FDA-determined cause: Software design
Action taken
The recalling firm issued letters dated 1/9/2019 via FedEx on 1/10/2019 to all EVOLIS customers.
Details
- Recall number
- Z-1906-2019
- Initiated
- January 10, 2019
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- 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.
- Recalling firm
- Bio-Rad Laboratories, Inc, Redmond, WA