Recall Z-0572-2014— Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Class II · Terminated
Class II FDA medical device recall by Clark Laboratories, Inc. (dba,Trinity Biotech USA), initiated 2013-08-27, terminated 2016-05-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results..
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-27
- Terminated
- 2016-05-24
- Firm location
- Jamestown, NY, United States
Product description
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.
Reason for recall
Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.