Recall Z-0572-2014 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
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
| Date | Dec 26, 2013 (initiated Aug 27, 2013) |
| Status | Terminated |
| Reason | Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results. |
| Root cause | Process design |
| Action | 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 D |
| Quantity | 38 kits |
| Distribution | USA Nationwide Distribution in the state of WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.