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U.S. Department of Health and Human Services

Class 2 Device Recall Captia Syphilis IgG

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  Class 2 Device Recall Captia Syphilis IgG see related information
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
510(K)Number K104233  
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.
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