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U.S. Department of Health and Human Services

Class 3 Device Recall AtheNA MultiLyte MMV Test System AtheNA MultiLyte MMRV Test System A93111G

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  Class 3 Device Recall AtheNA MultiLyte MMV Test System AtheNA MultiLyte MMRV Test System A93111G see related information
Date Initiated by Firm March 08, 2012
Date Posted May 08, 2012
Recall Status1 Terminated 3 on July 03, 2013
Recall Number Z-1500-2012
Recall Event ID 61646
510(K)Number K961204  
Product Classification Enzyme linked immunoabsorbent assay, mumps virus - Product Code LJY
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.
Code Information 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.) 
Recalling Firm/
Manufacturer		 Zeus Scientific, Inc.
200 Evans Way
Branchburg NJ 08876-3767
For Additional Information Contact Mr. Kevin Bielski
908-243-4915
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 180 kits
Distribution Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LJY and Original Applicant = ZEUS SCIENTIFIC, INC.
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