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.

Recall Insight

This FDA Devices action (record #Z-0572-2014) was formally reported on January 1, 2014, with the manufacturer initiating the action on August 27, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Clark Laboratories, Inc. (dba,Trinity Biotech USA) is listed as the recalling firm, operating out of Jamestown, NY. Federal records indicate 38 kits units are affected.

The documented reason for this recall is: Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results. Distribution data in the federal record shows the product reached: USA Nationwide Distribution in the state of WA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.