Device 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.
Z-0572-2014
Product summary
- Event
- Event 66916
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38 kits
- Official record key
device-enforcement:Z-0572-2014
Official wording
Reason: Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
Code information: Product Code: 800-960, Lot number: 082, Model: 10 - plate kit
Distribution pattern: USA Nationwide Distribution in the state of WA
Derived failure modes
-
Unknown
Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.