Z-1906-2019 Class II Ongoing
FDA device recall Z-1906-2019 was initiated by Bio-Rad Laboratories, Inc on January 10, 2019 and is designated Class II. 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 c… The recall status is ongoing. Affected quantity: 213 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2019
- Initiation Date
- January 10, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 213 devices
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).
Distribution Pattern
Distribution was nationwide to medical facilities, including to Puerto Rico. There was also government/military distribution. There was no foreign distribution.
Code Information
Software version 1.4, UDI for the software is 03610520562024.