EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
This recall is currently active, issued January 10, 2019. It was issued by Bio-Rad Laboratories, Inc.
- Company
- Bio-Rad Laboratories, Inc
- Recall Initiated
- January 10, 2019
- Recall Number
- Z-1906-2019
- Quantity
- 213 devices
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
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).
Distribution
Distribution was nationwide to medical facilities, including to Puerto Rico. There was also government/military distribution. There was no foreign distribution.
Lot / Code Info
Software version 1.4, UDI for the software is 03610520562024.
Root Cause
Software design
Action Taken
The recalling firm issued letters dated 1/9/2019 via FedEx on 1/10/2019 to all EVOLIS customers.