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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmNovember 09, 2001
Date PostedJuly 19, 2003
Recall Status1 Terminated 3 on October 03, 2006
Recall NumberZ-1031-03
Recall Event ID 26516
510(K)NumberK961277 
Product Classification System, Test, Rheumatoid Factor - Product Code DHR
ProductRheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.
Code Information Product Number: 507-B (Sigma Diagnostics) Lot Number: 090K6499 Expiration Date: 5-31-2002.  Product Number: 2Z921M (Zeus) Lot Number: 00010446 Expiration Date: 06-09-2002
Recalling Firm/
Manufacturer		 Zeus Scientific Inc
200 Evans Way
Branchburg NJ 08876
For Additional Information ContactMr. Mark Kopnitsky
908-526-3744
Manufacturer Reason
for Recall		Calibrator C not meeting its optical density specification.
FDA Determined
Cause 2		Other
ActionCustomers were notified of the recall via DHL on 11/9/2001. Customers were instructed to return or destroy product.
Quantity in Commerce505
DistributionThe Sigma product was shipped to Sigma directly. The Zeus product was shipped to customers nationwide via DHL. Zeus customers consists of hospitals, and clinical laboratories.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DHR
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