Class 2 Device Recall CMV IgM EIA

• Date Initiated by Firm: October 19, 2022
• Date Posted: December 06, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0342-2023
• Recall Event ID: 91106
• 510(K)Number: K982485
• Product Classification: Enzyme linked immunoabsorbent assay, cytomegalovirus - Product Code LFZ
• Product: CMV IgM EIA, in vitro diagnostic.
• Code Information: Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022
• Recalling Firm/ Manufacturer: Bio-Rad Laboratories, Inc.; 6565 185th Ave Ne; Redmond WA 98052-5039
• For Additional Information Contact: Anna Gralinska-Schram; 510-741-6643
• Manufacturer Reason for Recall: Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
• FDA Determined Cause: Nonconforming Material/Component
• Action: On or about 10/19/2022, the firm sent an "URGENT: Medical Device Recall" letter via UPS overnight to customers to inform them, Bio-Rad has received complaints of an unusual increase in the positivity rate with the Bio-Rad CMV IgM EIA kits. Customers are instructed to discontinue use and to dispose of any unused product of Batch NumbersB02022, E10022, and G05022 of the Bio-Rad CMV IgM EIA (Material No. 25178; GTIN/UDI 00847865010733) according to local waste management procedures. If you have further distributed or transferred the product to other Bio-Rad customers, or labs from your site, please be sure to notify those customers of this field action. For any questions regarding this information, please contact Bio-Rad Laboratories Technical Support at 1-800-2BIORAD (1-800-224-6723), option #2, and then option #3, or by emailing TechSupportUSSD-Redmond@Bio-Rad.com for further assistance.
• Quantity in Commerce: 180 kits
• Distribution: U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None
• 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.

• 510(K) Database: 510(K)s with Product Code = LFZ