| 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. |
| CBER Recall Notice |
Updated August 30, 2002
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