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.
This recall has been terminated (originally issued December 17, 2004).
- Company
- Diamedix Corporation
- Recall Initiated
- September 11, 2003
- Posted
- December 17, 2004
- Terminated
- October 5, 2009
- Recall Number
- Z-0325-05
- Quantity
- 490 kits
- Firm Location
- Miami, FL
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed to 54 laboratory accounts throughout the US.
Lot / Code Info
The kit lot number is 42003. The conjugate lot number is 42023.
Root Cause
Other
Action Taken
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.