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U.S. Department of Health and Human Services

Medical Devices

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Roche Diagnostics Tecan Clinical Workstation

Class I Recall
Date Recall
Initiated:

May 5, 2004

[See Also March 5, 2004 Recall for Same Device] (purge problem)
[See Also May 3, 2004 Recall for Same Device] (RoboNet software)
[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:
A software error in the workstation software may cause a mismatch among patient samples and test results 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 more information on this product recall, see the FDA Enforcement Report.