08-21-2003
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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
The FDA Center for Devices and Radiological Health posted a Class I recall notice for the ProbeTec ET Instrument, an in-vitro diagnostic medical device used for the detection of Chlamydia and gonorrhea in symptomatic and asymptomatic patients. The recalling firm is Becton Dickinson of Sparks, Maryland. A component of the in-vitro diagnostic device was incorrectly installed causing false positive and false negative results. Continued use of the defective instrument could result in a moderate to high risk of serious adverse health consequences, including death.
Read the 2003 MedWatch safety summary, including links to the CDRH recall notice at:
http://www.fda.gov/medwatch/SAFETY/2003/safety03.htm#ProbeTec
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