CMV IgM EIA, in vitro diagnostic.
This recall is currently active, issued December 6, 2022. It was issued by Bio-Rad Laboratories, Inc.
- Company
- Bio-Rad Laboratories, Inc
- Recall Initiated
- October 19, 2022
- Posted
- December 6, 2022
- Recall Number
- Z-0342-2023
- Quantity
- 180 kits
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
Distribution
U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None
Lot / Code Info
Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022
Root Cause
Nonconforming Material/Component
Action Taken
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.