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.
FDA Recall Z-1500-2012 · Posted 2012-05-08
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Recalling FirmZeus Scientific, Inc.
Recall StatusTerminated
Product CodeLJY
Date Initiated2012-03-08
Date Terminated2013-07-03
Product Quantity180 kits
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.
Firm 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 [email protected].
If you have any questions, call 908-526-3744 or 800-286-2111.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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