Z-1500-2012

AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay intended for the qualitative...

Name: Z-1500-2012 AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay intended for the qualitative...
Creator: Zeus Scientific, Inc.
Published: 2012-03-08
License: https://open.fda.gov/license/

Zeus Scientific LLC / initiated 2012-03-08 / Terminated / root cause: manufacturing process

FDA source

Zeus Scientific, Inc. began a recall of AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay intended for the qualitative presumptive detection of IgG class antibody to the... on 2012-03-08. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1500-2012
Status: Terminated
Initiated: 2012-03-08
Posted: 2012-05-08
Terminated: 2013-07-03
Recalling firm: Zeus Scientific LLC
Product: 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.
Product code: LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. If you have any questions, call 908-526-3744 or 800-286-2111.
Quantity in commerce: 180 kits
Distribution: Nationwide distribution.
Product codes and lots: 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.)

Product code LJY

K961204Class IMumps Igg TestZeus Scientific, Inc. / cleared 1996-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)