Reported Jan 1, 2014 · Terminated
Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies…
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Clark Laboratories, Inc. (dba,Trinity Biotech USA) · 2823 Girts Road · Jamestown, NY · 14701
Is this the product you have?
- Captia
- Syphilis-G Test Kit Product UsageThis 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
- Lot codes and dates
- Product Code800-960
- Lot number082
- Model10 - plate kit
- Amount recalled
- 38 kits
Where it was sold
- Nationwide
- WA
Why it was recalled
Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
This product could cause temporary or reversible health problems — stop using it.
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