Recall Z-0342-2023 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Bio-Rad Laboratories, Inc.
CMV IgM EIA, in vitro diagnostic.
| Date | Dec 6, 2022 (initiated Oct 19, 2022) |
| Status | Open, Classified |
| Reason | Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA). |
| 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, ple |
| Quantity | 180 kits |
| Distribution | U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982485 | SERAQUEST CMV IGM Quest Intl., Inc., Jan 13, 1999 |