AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay intended for the qualitative presumptive de
FDA device recall Z-1500-2012 · posted 2012-05-08 · Terminated
Recall details
- Recalling firm
- Zeus Scientific, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LJY
- Quantity affected
- 180 kits
- Distribution
- Nationwide distribution.
- Date initiated
- 2012-03-08
- Date posted
- 2012-05-08
- Date terminated
- 2013-07-03
- Location
- Branchburg, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MUMPS IGG TEST (K961204) | Zeus Scientific, Inc. | 1996-07-18 |