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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm March 19, 2001
Date Posted July 02, 2003
Recall Status1 Terminated 3 on October 03, 2006
Recall Number Z-0961-03
Recall Event ID 26402
Product Classification Enzyme Linked Immunoabsorbent Assay, Rubeola Igg - Product Code LJB
Product Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055
Code Information Lot No: 00008066; Expiration Date: 08-11-2001.
Recalling Firm/
Zeus Scientific Inc
200 Evans Way
Branchburg NJ 08876
For Additional Information Contact Mr. Mark J. Kopnitsky
Manufacturer Reason
for Recall
Mix-up between low positive and negative controls.
FDA Determined
Cause 2
Action Recall letter was sent via DHL to Biotest on 3/19/2001. Product was to be returned to Zeus.
Quantity in Commerce 15 kits
Distribution NJ
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.