FDA Safety Information and Adverse Event Reporting Program

The FDA and Roche Diagnostics notified healthcare professionals of a Class I Recall for the Tecan Clinical Workstation (TCW), used with Roche Diagnostics Amplicor CT/NG test for the detection of Chlamydia and gonorrhea.  A software error in the workstation software may cause a mismatch among patient samples and test results resulting in false positive and false negative results.  This could lead to mistreatment and unneeded exposure to antibiotics.  Untreated Chlamydia and gonorrhea infections may lead to pelvic inflammatory disease, infertility, ectopic pregnancy, or other conditions. 

Read the MedWatch 2004 safety summary, including a link to the FDA recall notice, at:

http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#tecan