Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies

FDA device recall Z-0572-2014 · posted 2013-12-26 · Terminated

Recall details

Recalling firm

Clark Laboratories, Inc. (dba,Trinity Biotech USA)

Reason for recall

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

Action taken

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.

Root cause

Process design

Status

Terminated

Product code

LIP

Quantity affected

38 kits

Distribution

USA Nationwide Distribution in the state of WA

Date initiated

2013-08-27

Date posted

2013-12-26

Date terminated

2016-05-24

Location

Jamestown, NY