Z-0819-2015Class III

Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96...

Name: Z-0819-2015 Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96...
Creator: Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Published: 2014-11-17
License: https://open.fda.gov/license/

Trinity Biotech USA / initiated 2014-11-17 / Terminated / root cause: labeling and UDI

FDA source

Clark Laboratories, Inc. (dba,Trinity Biotech USA) began a recall of Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an... on 2014-11-17. FDA classified it as Class III and gives the reason as "Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0819-2015
Classification: Class III
Status: Terminated
Initiated: 2014-11-17
Posted: 2014-12-16
Terminated: 2016-05-24
Recalling firm: Trinity Biotech USA
Product: Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.
Product code: LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Reason for recall: Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Recall notification letters were sent by e-mail to 2 US customers on 11/17/2014 and 11/19/2014. The remaining US customers were sent the letter by FedEx on 11/19/2014. Customers are instructed to discontinue use of any remaining inventory (discard on site if any remain) and provide date of last use (run) and if they obtained valid or invalid runs. Additionally, Trinity is in the process of sending the recall letters to the required EU Regulatory Authorities and the 3 foreign distributors.
Quantity in commerce: Domestic: 9 kits; Foreign: 26 kits
Distribution: New York, Florida, Utah, and California plus foreign distribution to Spain and France
Product codes and lots: Lot 033, expiry date 30 November 2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0819-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0819-2015	Class III	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-16

Product code LIP

K904524Class IICaptia(r) Syphilis M, ModificationMercia Diagnostics , Ltd. / cleared 1990-12-26

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)