Class 1 recall of Becton Dickinson ProbeTec ET Uri ne Processsing Kit due to false negative results

Date: Tue, 1 Feb 2005 12:22:59 -0500

From: CDER MEDWATCH LISTSERV


Subject: FDA MedWatch -


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.




Date Recall
Initiated January 10, 2005
Product: Becton Dickinson Diagnostic Systems ProbeTec ET Urine Processing Kit
Use: The BD ProbeTec 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 ProbeTec? 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
email: technical_services@bd.com
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 Becton Dickinson press release at: http://www.fda.gov/cdrh/recalls/recall-011005-pressrelease.pdf.