CMV IgM EIA, in vitro diagnostic.
FDA device recall Z-0342-2023 · posted 2022-12-06 · Open, Classified
Recall details
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Reason for recall
- Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- LFZ
- Quantity affected
- 180 kits
- Distribution
- U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None
- Date initiated
- 2022-10-19
- Date posted
- 2022-12-06
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SERAQUEST CMV IGM (K982485) | Quest Intl., Inc. | 1999-01-13 |