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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 August 30, 2004
Date Posted November 20, 2004
Recall Status1 Terminated 3 on October 03, 2006
Recall Number Z-0214-05
Recall Event ID 29963
510(K)Number K981021  
Product Classification System, Test, Anticardiolipin Immunological - Product Code MID
Product Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box.
Code Information Lot 04027128 exp 2005-10
Recalling Firm/
Manufacturer
Zeus Scientific Inc
200 Evans Way
Somerville NJ 08876-3767
For Additional Information Contact Mark Kopnitsky
800-286-2111 Ext. 237
Manufacturer Reason
for Recall
During packaging, Lyme plates were packaged in this kit in error.
FDA Determined
Cause 2
Other
Action Wampole Laboratories was contacted by Zeus on 8/30/3004. Wampole customers were then contacted by phone and letter to destroy all products on hand.
Quantity in Commerce 25 kits
Distribution 25 units were sent directly from Zeus to their direct account Wampole Laboratories. The distributor contacted their customers to discard all affected kits. 8 units were shipped overseas to Israel. There were no ships to government facilities.
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.
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