Class 3 Device Recall IsSyphilis TREPCHEK Test Kit.

• Date Initiated by Firm: September 11, 2003
• Date Posted: December 17, 2004
• Recall Status: Terminated on October 05, 2009
• Recall Number: Z-0325-05
• Recall Event ID: 30165
• 510(K)Number: K001552
• Product Classification: Enzyme Linked Immunoabsorption Assay, Treponema Pallidum - Product Code LIP
• Product: The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be used either manually or in conjunction with the MAGO Plus or APTUS Automated EIA Processors. The FDA has not cleared this product for use in screening blood or plasma donors. The kit is labeled with an expiration date of Mar 04 and requires storage at 2-8 degree Centigrade.The non conforming kit component is the Conjugate that consists of a glass bottle with red cap containing 30 ml goat anti-human IgG labeled with horseradish peroxidase.
• Code Information: The kit lot number is 42003. The conjugate lot number is 42023.
• Recalling Firm/ Manufacturer: Diamedix Corporation; 2140 N Miami Ave; Miami FL 33127-4916
• Manufacturer Reason for Recall: Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to be called invalid.
• FDA Determined Cause: Other
• Action: Recall letter dated 10/8/03 was sent, via FEDEX, with replacement conjugate bottles to those accounts reporting remaining stock.The letter requested that the original conjugate bottle, lot number 42023 be discarded and replaced with new conjugate lot #71323z. The letter also included a new inner box label that had the lot number information for the new conjugate bottle.
• Quantity in Commerce: 490 kits
• Distribution: Distributed to 54 laboratory accounts throughout the US.
• 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