U.S. Food and Drug Administration - CDRH Mobile
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 | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule

FDA > CDRH > Medical Device Recalls > Class I Recall - Roche Diagnostics Tecan Clinical Workstation

Medical Device Recalls
Class I Recall: Roche Diagnostics Tecan Clinical Workstation

Date Recall
Initiated:

March 5, 2004

[See Also May 3, 2004 Recall for Same Device] (RoboNet software)
[See Also May 5, 2004 Recall for Same Device] (software error)
[See Also May 5, 2004 Recall for Same Device] (COBAS GUI Interface)

Product:
 Tecan Clinical Workstation configured with the Roche Diagnostics Amplicor CT/NG Analyzer.
Use:
 The Tecan Clinical Workstation is a multiple-task instrument used in clinical laboratories for the detection of Chlamydia and gonorrhea.
Recalling Firm:
 Roche Diagnostics Corporation
9115 Hague Road
Indianapolis, IN 46256-1025
Reason for Recall:
 If the operator of the workstation fails to purge the workstation's data management system on a regular basis, the workstation's software may mismatch sample results and sample identification resulting in false positive and false negative results.
Public Contact:
 Roche Molecular Diagnostics Technical Support Center
800-526-1247
FDA District:
 Detroit
FDA Comment:
 False positive and false negative results could lead to mistreatment and unneeded exposure to antibiotics. Untreated Chlamydia and gonorrhea infections may lead to pelvic inflammatory disease, infertility, ectopic pregnancy, or other conditions. Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.
 

For additional information on this product recall, see the Roche press release at: http://www.fda.gov/cdrh/oivd/letters/050704-roche.html.

Updated June 18, 2004

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