News & Events
BD Supplemental Statement Regarding Voluntary Recall of BD ProbeTec™ ET Instrument
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Contact: Colleen T. White Corporate Communications (201) 847-5369 Email: colleen_white@bd.com Charles A. Borgognoni Corporate Communications (201) 847-6651 Franklin Lakes, NJ (October 30, 2003) -- BD (Becton, Dickinson and Company) (NYSE: BDX) today provided an update for Canada regarding the voluntary recall of the BD ProbeTec™ ET instrument for the detection of chlamydia and gonorrhea, initiated July 21, 2003. The voluntary recall was initiated due to one report from the field in the U.S. regarding a defect discovered in the course of instrument evaluation. On that date, all Canadian customers were contacted and asked to perform a test to verify the functioning of each instrument.
Only one defective unit was located in a Canadian institution, and it was immediately replaced. 100% of other Canadian institutions using the BD ProbeTec ET™ instrument have confirmed testing and verified proper functioning
BD has been working with the affected institution to assist in the determination of the impact to patient results and to ensure notification of physicians of impacted patients. While several thousand patients were tested, based on the instrument defect, the test results for the vast majority of patients would have been correct. Nevertheless, BD is supportive of the efforts of the B.C. Interior Health Authority to communicate with all of the patients tested from November 1, 2000 to May 24, 2002.
As indicated in BD's statement of August 22, 2003, BD initiated a worldwide corrective action notifying customers and asking them to perform a test to verify the functioning of each instrument. All of the BD ProbeTec ET™ instruments that have been tested worldwide have been verified as functioning properly.
Patient safety and the efficacy of our products are always the primary concerns of BD, and anyone with questions or concerns should contact Althea Lawrence at 1-800-268-5430, ext. 5524 or via email at althea_lawrence@bd.com.
BD is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products. For the fiscal year ended September 30, 2002, BD reported total revenues of $4.033 billion.
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