Bio-Rad Laboratories, Inc. CMV IgM EIA, in vitro diagnostic. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CMV IgM EIA, in vitro diagnostic.
Brand
Bio-Rad Laboratories, Inc.
Lot Codes / Batch Numbers
Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022
Products Sold
Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022
Bio-Rad Laboratories, Inc. is recalling CMV IgM EIA, in vitro diagnostic. due to Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, GA, HI, IA, MA, MN, NH, NJ, NC, PA, TN, TX
Page updated: Jan 10, 2026