Class 2 Device Recall Zeus

• Date Initiated by Firm: June 12, 2003
• Date Posted: August 12, 2003
• Recall Status: Terminated 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: 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