Clark Laboratories, Inc. (dba,Trinity Biotech USA): Medical Device Recall in 2014 - (Recall #: Z-0572-2014)

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:

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 Classification:

Class II

Date Initiated: August 27, 2013

Date Posted: January 1, 2014

Recall Number: Z-0572-2014

Event ID: 66916

Reason for Recall:

Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.

Status: Terminated

Product Quantity: 38 kits

Code Information:

Product Code: 800-960, Lot number: 082, Model: 10 - plate kit

Distribution Pattern:

USA Nationwide Distribution in the state of WA

Voluntary or Mandated:

Voluntary: Firm initiated