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U.S. Department of Health and Human Services

Medical Devices

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Becton Dickinson ProbeTec ET Urine Processing Kit

Class I Recall
Date Recall
Initiated:
January 10, 2005
Product:
Becton Dickinson Diagnostic Systems ProbeTec ET Urine Processing Kit
Use:
The BD ProbeTecâ„¢ ET Urine Processing Kit contains urine processing pouches which are designed to aid in testing male and female urine specimens for Chlamydia and gonorrhea with the BD ProbeTecâ„¢ ET System. The urine processing pouch is an optional accessory that may be added at the collection site or laboratory test site.
Recalling Firm:
Becton Dickinson Diagnostics Systems
7 Loveton Circle
Sparks, MD 21152-9212
Reason for Recall:
This laboratory test may cause indeterminate and false negative clinical results which could lead to the patient not receiving treatment for the disease. Untreated infection could result in worsening infections, further disease transmission, pelvic inflammatory disease, infertility, ectopic pregnancy and other sequellae.
Public Contact:
Becton Dickinson Technical Service
1-800-666-6433, extension 4331
FDA District:
Baltimore
FDA Comment:
The firm notified their customers via telephone on January 10th, 2005 of this problem. A recall notification by mail followed and included a letter for the laboratories to provide to physicians. Laboratories were advised to discontinue use of the kits and discard for replacement.
FDA considers that the probability of life threatening consequences is likely to occur by use of these products. Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.
 

For additional information on this product recall, see the nearby links.

After you go to the Enforcement Report, scroll down in the report to Recalls and Field Corrections:Devices - Class I.