FDA MedWatch - Class 1 recall of Becton Dickinson ProbeTec ET Urine Processsing Kit

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA and Becton Dickinson notified healthcare professionals of a Class 1

recall of the ProbeTec ET Urine Processing Kit, designed to aid in testing

male and female urine specimens for Chlamydia and gonorrhea. This laboratory

test may cause indeterminate and false negative clinical results which could

lead to the patient not receiving treatment. Untreated infection could

result in worsening infections, further disease transmission, pelvic

inflammatory disease, infertility, ectopic pregnancy and other sequellae.

Read the complete MedWatch 2005 safety summary, including links to the FDA

Recall notice, at

http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#probetec