Class I Medical Device Recalls - CAPTIA Syphilis G Elisa Test Kit

Center for Devices and Radiological Health, U.S. Food and Drug Administration

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH
horizonal rule

Medical Device Recalls
Class I Recall: CAPTIA Syphilis G Elisa Test Kit

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

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH