• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

CAPTIA Syphilis G Elisa Test Kit

Class 1 Recall

Date Recall
Initiated
July 22, 2002
Product:
CAPTIA Syphilis G Elisa Test Kit
Lot Numbers K00841, K00842, K00838 and K00839
Use:
This product is a diagnostic test used to detect syphilis in the blood and to screen blood and/or plasma donors by blood banks to rule out a history of syphilis.
Recalling Firm:
Trinity Biotech plc
IDA Business Park, Bray
Co. Wicklow, Ireland
Reason for Recall:
Blood and/or plasma samples tested with the affected lots can provide a false negative result. In other words, blood and/or plasma samples with a history of syphilis could return a result of no history for syphilis. The potentially false negatives are due to a shift in the performance of the Low Titre Positive Control in the lots mentioned above. This shift in performance can cause blood/plasma samples to result in low positive readings equivalent to negatives.
Public Contact:
Bonnie Dejoy
Director of Quality Systems
Trinity Biotech
2823 Girts Road
Jamestown, NY 14701
(716) 483-3851
Distribution:
The product was distributed in the following US states; CA, FL, MN, NJ and PA, between May 16, 2002 and May 31, 2002.
FDA District:
New York District/Buffalo
FDA Comment:
FDA considers there to be high risk of adverse health consequences from continued use of lots K00841, K00842, K00838 and K00839. Blood and/or plasma samples tested on these lots should be retested.