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. |
For additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2003/ENF00812.html. Scroll down to "Recalls and Field Corrections: Devices – Class I". |
Updated September 11, 2003
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