Class 3 Device Recall

• Date Initiated by Firm: June 22, 2001
• Date Posted: August 21, 2003
• Recall Status: Terminated 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/ Manufacturer: Zeus Scientific Inc; 200 Evans Way; Branchburg NJ 08876
• For Additional Information Contact: Mr. Mark Kopnitsky; 908-526-3744
• Manufacturer Reason for Recall: Bacterial contamination of the high positive control.
• FDA Determined Cause: Other
• 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.