CMV IgM EIA, in vitro diagnostic recallZ-0342-2023 · Bio-Rad Laboratories, Inc. · initiated Oct 19, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bio-Rad Laboratories, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0342-2023
- Status
- Open, Classified
- Initiated by the company
- Oct 19, 2022
- Posted by the FDA
- Dec 6, 2022
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Quantity
- 180 kits
- Product code
- LFZ
- FDA submissions
- K982485
- Distribution
- U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None
Product description
CMV IgM EIA, in vitro diagnostic.
Code information (models, lots, serial numbers)
Catalog Number: 25178 UDI-DI Code: 00847865010733 Lot Numbers: B02022 E10022 G05022
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Bio-Rad Laboratories, Inc. 25178Bio-RAD Laboratories, Inc. · ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page