Class 3 Device Recall TrepChek Syphilis Test Kit

• Date Initiated by Firm: March 16, 2005
• Date Posted: April 28, 2005
• Recall Status: Terminated on July 22, 2006
• Recall Number: Z-0784-05
• Recall Event ID: 31710
• 510(K)Number: K001552
• Product Classification: Enzyme Linked Immunoabsorption Assay, Treponema Pallidum - Product Code LIP
• Product: Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2.
• Code Information: lot # 041207T expiration date 9-30-2005
• Recalling Firm/ Manufacturer: Diasorin Inc.; 1951 Northwestern Ave S; Stillwater MN 55082-7536
• Manufacturer Reason for Recall: Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter.
• FDA Determined Cause: Other
• Action: Customers were contacted via telephone, informed of the incorrect package insert, asked to destroy any incorrect inserts and a correct insert was faxed to customers.
• Quantity in Commerce: 14 kits
• Distribution: MA, CA, TX, KS, NY, FL
• 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 = LIP