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.
- Company
- Zeus Scientific, Inc.
- Recall Initiated
- March 8, 2012
- Posted
- May 8, 2012
- Terminated
- July 3, 2013
- Recall Number
- Z-1500-2012
- Quantity
- 180 kits
- Firm Location
- Branchburg, NJ
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.
Distribution
Nationwide distribution.
Lot / Code Info
11120087 11120165 11110125 : (This is an amendment to add the additional lot 11110125 which was left off.. This amendment was made on 6/6/2012.)
Root Cause
Nonconforming Material/Component
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.