Z-0572-2014 Class II Terminated
FDA device recall Z-0572-2014 was initiated by Clark Laboratories, Inc. (dba,Trinity Biotech USA) on August 27, 2013 and is designated Class II. Reason for recall: Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results. The recall status is terminated (terminated May 24, 2016). Affected quantity: 38 kits.
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2014
- Initiation Date
- August 27, 2013
- Termination Date
- May 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38 kits
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.
Distribution Pattern
USA Nationwide Distribution in the state of WA
Code Information
Product Code: 800-960, Lot number: 082, Model: 10 - plate kit