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U.S. Department of Health and Human Services

Safety

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Becton Dickinson ProbeTec ET Urine Processsing Kit

Audience: Laboratory supervisory personnel and healthcare professionals

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.

[January 31, 2005 - Recall Notice - FDA]