Z-0342-2023Class II

CMV IgM EIA, in vitro diagnostic

Name: Z-0342-2023 CMV IgM EIA, in vitro diagnostic
Creator: Bio-Rad Laboratories, Inc.
Published: 2022-10-19
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2022-10-19 / Open, Classified / root cause: manufacturing process

FDA source

Bio-Rad Laboratories, Inc. began a recall of CMV IgM EIA, in vitro diagnostic on 2022-10-19. FDA classified it as Class II and gives the reason as "Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0342-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-19
Posted: 2022-12-06
Recalling firm: Bio-Rad Laboratories Inc.
Product: CMV IgM EIA, in vitro diagnostic.
Product code: LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Reason for recall: Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
Root cause tag: manufacturing process
FDA root 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 [email protected] 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
Product codes and lots: Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0342-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0342-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-07	2022-11-30

Product code LFZ

K982485Class IISeraquest Cmv IgmQuest Intl., Inc. / cleared 1999-01-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)