Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health
horizonal rule

Medical Device Recalls
Class 1 Recall: ProbeTec ™ ET Instrument
See Related Information
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

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH