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U.S. Department of Health and Human Services

Medical Devices

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ProbeTec ET Instrument

Class I Recall
Date Recall
Initiated:
July 21, 2003
Product:
ProbeTec™ ET Instrument
Use:
The instrument is an in-vitro diagnostic medical device used for the detection of Chlamydia and gonorrhea in symptomatic patients (patients who have symptoms of the disease) and in asymptomatic patients (patients without symptoms of the disease).
Recalling Firm:
Becton Dickinson & Co.
7 Loveton Circle
Sparks, Maryland 21152
Reason for Recall:
A component of the in-vitro diagnostic device was incorrectly installed causing false positive and false negative results in both symptomatic and asymptomatic patients.
Public Contact:
Gail Claiborne
Quality Management/Regulatory Compliance
410-316-4054
FDA District:
Baltimore
FDA Comment:
Continued use of the defective instrument could result in a moderate to high risk of serious adverse health consequences, including death.