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.
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