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U.S. Department of Health and Human Services

Safety

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ProbeTec ET Instrument

Audience: Clinical Microbiologists, Hospital Laboratory Staff and Risk Managers

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.

[August 21, 2003 - CDRH Recalls Page - FDA]