Z-0325-05

The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative...

Name: Z-0325-05 The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative...
Creator: Diamedix Corporation
Published: 2003-09-11
License: https://open.fda.gov/license/

Diamedix Corp. / initiated 2003-09-11 / Terminated / root cause: manufacturing process

FDA source

Diamedix Corporation began a recall of 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... on 2003-09-11. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0325-05
Status: Terminated
Initiated: 2003-09-11
Posted: 2004-12-17
Terminated: 2009-10-05
Recalling firm: Diamedix Corp.
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.
Product code: LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: The kit lot number is 42003. The conjugate lot number is 42023.

Product code LIP

K001552Class IITrepchek Treponemal Antibody EiaPhoenix Biotech Corp. / cleared 2000-10-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)