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U.S. Department of Health and Human Services

Class 2 Device Recall Zeus

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  Class 2 Device Recall Zeus see related information
Date Initiated by Firm June 12, 2003
Date Posted August 12, 2003
Recall Status1 Terminated 3 on February 22, 2006
Recall Number Z-1095-03
Recall Event ID 26589
510(K)Number K891081  
Product Classification Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus - Product Code LFZ
Product Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.
Code Information Product Number 9Z9501G Lot Number: 03022371 exp. 2004-July; 03022392 exp. 2004-July; 03022472 exp 2004-July.
Recalling Firm/
Manufacturer
Zeus Scientific Inc
200 Evans Way
Branchburg NJ 08876
For Additional Information Contact Mr. Mark J. Kopnitsky
908-526-3744
Manufacturer Reason
for Recall
The Calibrator included within the kit may be losing reactivity.
FDA Determined
Cause 2
Other
Action All customers were notified via recall letter on June 12, 2003. Letter sent out via Airborne Express. All product is to be returned to Zeus or destroyed.
Quantity in Commerce 270 kits
Distribution The product was distributed to 6 distributors and 24 direct accounts in the United States and Internationally. Canada; Sweden; Costa Rica; Czech; Indonesia.
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 = LFZ and Original Applicant = ZEUS SCIENTIFIC, INC.
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