Recall Z-1500-2012 ยท LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Zeus Scientific, Inc.
AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay intended for the qualitative presumptive detection of IgG class antibody to the Mumps virus in human serum using the AtheNA Multi-Lyte Test System. The test system is intended to be used for determination of a previous infection with the Mumps virus.
| Date | May 8, 2012 (initiated Mar 8, 2012) |
| Status | Terminated |
| Reason | Select lots of AtheNA Multi-Lyte MMV Test System have lost reactivity and may produce false positive results in seronegative patients who have not been previously affected with or vaccinated against Mumps. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Zeus Scientific, sent an "URGENT NOTICE; Voluntary Product Recall" letter dated March 8, 2012 their customers via Fed Ex. The letter described the product, problem and actions to be taken. The customers were instructed to remove and discard any remaining inventory of the listed product; if you are not the end-user and/or you have distributed these products to customers, notify them accordingly; and complete, sign and return the verification notice via fax to: 908-526-2058 or email a PDF to support@zeusscientific.com. If you have any questions, call 908-526-3744 or 800-286-2111. |
| Quantity | 180 kits |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961204 | MUMPS IGG TEST Zeus Scientific, Inc., Jul 18, 1996 |