Z-0572-2014Class II

Captia Syphilis-G Test Kit

Name: Z-0572-2014 Captia Syphilis-G Test Kit
Creator: Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Published: 2013-08-27
License: https://open.fda.gov/license/

Trinity Biotech USA / initiated 2013-08-27 / Terminated / root cause: manufacturing process

FDA source

Clark Laboratories, Inc. (dba,Trinity Biotech USA) began a recall of Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to... on 2013-08-27. FDA classified it as Class II and gives the reason as "Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results". 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-0572-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-27
Posted: 2013-12-26
Terminated: 2016-05-24
Recalling firm: Trinity Biotech USA
Product: Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.
Product code: LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Reason for recall: Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Trinity Biotech issued an Urgent Product Information Request letter to their customer on August 27, 2013. The letter identified the affected product, problem and actions to be taken. The request was to determine if their customer did or did not backfill microtiter-strips during the analytical process. If a customer backfilled, they were advised to return the completed request form. On September 11, 2013 Trinity Biotech issued a notice to their customers advising them to re-evaluate any negative patient results for those who perform backfilling. For questions contact Trinity Biotech Help Desk at 800-325-3424, option 2.
Quantity in commerce: 38 kits
Distribution: USA Nationwide Distribution in the state of WA
Product codes and lots: Product Code: 800-960, Lot number: 082, Model: 10 - plate kit

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0572-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0572-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-26

Product code LIP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)