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FDA Issues Class 1 Recall on Urine Processing Kit, Citing False Outcomes


 

The Food and Drug Administration has issued a Class 1 recall of the ProbeTecET Urine Processing Kit, designed to aid in testing female and male urine specimens for chlamydia and gonorrhea.

The laboratory test—made by Becton Dickinson Diagnostic Systems—may cause indeterminate or 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.

Class 1 recalls are the most serious type of recall and involve situations where there is a reasonable probability of serious injury or death.

To contact the company, call 1-800-666-6433, extension 4331, or send an e-mail to technical_services@bd.com

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