Recall -- Firm Press Release
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BD Statement Regarding Worldwide Voluntary Recall of BD ProbeTecT ET Urine Processing Kits
Colleen T. White
FOR IMMEDIATE RELEASE -- Franklin Lakes, NJ -- January 28, 2005 -- BD (Becton, Dickinson and Company) (NYSE:BDX) has executed a voluntary product recall of certain lots of Urine Processing Kits, Catalog #440454. This field corrective action included notification to customers worldwide by telephone and by letter.
The Urine Processing Kit is designed to remove amplification inhibitors for testing urine specimens with Chlamydia trachomatis and Neisseria gonorrhoeae amplified DNA assays. These two organisms are common causes of sexually transmitted infections in both men and women.
The recall was initiated on January 10, 2005 after complaints were received regarding an increased level of indeterminate results from urine specimens stored with a urine processing pouch (UPP) at refrigerated temperatures. The impacted lots of UPPs were distributed between February and August 2004.
BD also found an increased risk of false negative results if the Amplification Control (AC) was not used during testing. Patients with false negative results who were not treated for these sexually transmitted infections may either unknowingly remain infected or experience continued symptoms. In addition, there is an increased risk of transmitting these infections to unprotected sexual partners.
A root cause has been identified and BD has adopted additional quality inspection and testing to assure that all other product performs acceptably.
The lots were distributed in the United States and Europe, with smaller amounts distributed to Australia and Canada. BD continues to work with the impacted customers, as patient safety and the efficacy of our products are BD's first priorities.
BD has notified the U.S. Food and Drug Administration and other worldwide health agencies as necessary, and is working with them to coordinate recall activities. Laboratories and/or physicians with questions can contact BD at 1-800-638-8663 in the U.S. and the appropriate BD representatives in Europe, Canada, and Australia.