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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 February 24, 2000
Date Posted July 30, 2003
Recall Status1 Terminated 3 on October 25, 2004
Recall Number Z-1065-03
Recall Event ID 26562
510(K)Number K984180  
Product Classification Enzyme Linked Immunoabsorbent Assay, Rubella - Product Code LFX
Product Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B
Code Information Product Number: 514-B (Sigma Diagnostics) Lot Numbers: 020K6491 Exp. 10-02-2001; 090K6483 Exp. 5-31-2002.
Recalling Firm/
Zeus Scientific Inc
200 Evans Way
Branchburg NJ 08876
For Additional Information Contact Mark Kopnitsky
Manufacturer Reason
for Recall
The high positive control/low positive standard ratio recovering too low.
FDA Determined
Cause 2
Action Recall letters sent out via DHL on 2/24/2000
Quantity in Commerce 205
Distribution The two lots were shipped to St. Louis, MO. No subrecall was initiated.
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 = LFX and Original Applicant = ZEUS SCIENTIFIC, INC.