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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 June 22, 2001
Date Posted August 21, 2003
Recall Status1 Terminated 3 on August 20, 2003
Recall Number Z-1147-03
Recall Event ID 26578
510(K)Number K984173  
Product Classification System, Test, Anticardiolipin Immunological - Product Code MID
Product Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.
Code Information Sigma Product number 552-B; Lot Number 060K6464 Expiration Date: 12-05-2001
Recalling Firm/
Zeus Scientific Inc
200 Evans Way
Branchburg NJ 08876
For Additional Information Contact Mr. Mark Kopnitsky
Manufacturer Reason
for Recall
Bacterial contamination of the high positive control.
FDA Determined
Cause 2
Action Recall letter were sent via DHL to consignee on 6/22/2001 which instructed to return or discard any remaining inventory.
Quantity in Commerce 130
Distribution All product was shipped to St. Louis, MO
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 = MID and Original Applicant = ZEUS SCIENTIFIC, INC.