Date Initiated by Firm | August 27, 2013 |
Date Posted | December 26, 2013 |
Recall Status1 |
Terminated 3 on May 24, 2016 |
Recall Number | Z-0572-2014 |
Recall Event ID |
66916 |
Product Classification |
Enzyme linked immunoabsorption assay, treponema pallidum - Product Code LIP
|
Product | 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. |
Code Information |
Product Code: 800-960, Lot number: 082, Model: 10 - plate kit |
Recalling Firm/ Manufacturer |
Clark Laboratories, Inc. (dba,Trinity Biotech USA) 2823 Girts Road Jamestown NY 14701
|
For Additional Information Contact | 716-483-3851 |
Manufacturer Reason for Recall | Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results. |
FDA Determined Cause 2 | 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 Desk at 800-325-3424, option 2. |
Quantity in Commerce | 38 kits |
Distribution | USA Nationwide Distribution in the state of WA |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|