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Clark Laboratories, Inc. (dba,Trinity Biotech USA) recalls Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibod
Recalled January 1, 2014 · FDA recall Z-0572-2014 · Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Hazard
Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results. · FDA Class II
Units
38 kits
Sold at
USA Nationwide Distribution in the state of WA
Description
Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
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.
Manufacturer(s)
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →