Clark Laboratories, Inc. (dba,Trinity Biotech USA): Medical Device Recall in 2014 - (Recall #: Z-0819-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: November 17, 2014

Date Posted: December 24, 2014

Recall Number: Z-0819-2015

Event ID: 69827

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.

Status: Terminated

Product Quantity: Domestic: 9 kits; Foreign: 26 kits

Code Information:

Lot 033, expiry date 30 November 2014

Distribution Pattern:

New York, Florida, Utah, and California plus foreign distribution to Spain and France

Voluntary or Mandated:

Voluntary: Firm initiated