• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Captia Syphilis IgG

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Captia Syphilis IgG
see related information
Date Posted December 26, 2013
Recall Status1 Open
Recall Number Z-0572-2014
Recall Event ID 66916
Premarket Notification
510(K) Number
K014233 
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, New York 14701
Manufacturer Reason
for Recall
Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
FDA Determined
Cause 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LIP and Original Applicant = TRINITY BIOTECH, PLC
-
-