Class 2 Device Recall EVOLIS Microplate System with TimeLiner Data Management Software

• Date Initiated by Firm: January 10, 2019
• Create Date: June 30, 2019
• Recall Status: Open, Classified
• Recall Number: Z-1906-2019
• Recall Event ID: 82920
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
• Code Information: Software version 1.4, UDI for the software is 03610520562024.
• FEI Number: 3008272466
• Recalling Firm/ Manufacturer: Bio-Rad Laboratories, Inc; 6565 185th Ave Ne; Redmond WA 98052-5039
• For Additional Information Contact: Mr. Tina Cuccia; 510-741-6063
• Manufacturer 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: The recalling firm issued letters dated 1/9/2019 via FedEx on 1/10/2019 to all EVOLIS customers.
• Quantity in Commerce: 213 devices
• Distribution: Distribution was nationwide to medical facilities, including to Puerto Rico. There was also government/military distribution. There was no foreign distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.