Recall of CAPTIA Syphilis G (T. Pallidum) Kit DATE RECALL INITIATED: July 17, 2002 LOT NUMBERS / EXPIRATION DATE: K00838 1/14/2003 K00839 1/14/2003 K00841 1/14/2003 K00842 1/14/2003 (A letter may suffix these lots) MANUFACTURER: Trinity Biotech plc. Co. Wicklow, Ireland DISTRIBUTOR: Medpoint Somerset, NJ Adalitis, US Inc. Allentown, PA DiaSorin Inc. Still Water, MN Grifols - Quest Miami, FL Bio-Rad Hercules, CA REASON: In response to customer complaints, the manufacturer found a potential shift in performance in that samples tested could give reduced signals resulting in shifting from low positive/equivocal to negatives (false negatives). CDRH Recall Notice The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed. Last Updated: 8/13/2002