FDAFDA · Food and drugs·Recall number Z-0572-2014
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.
Published January 1, 2014 · Recall initiated: August 27, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Distributor
- USA Nationwide Distribution in the state of WA
- Lot
- Product Code: 800-960, Lot number: 082, Model: 10 - plate kit
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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