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U.S. Department of Health and Human Services

Medical Devices

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Roche Diagnostics COBAS GUI Software for the 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] (software error)

Product:

COBAS GUI Software Interface between the Tecan Clinical Workstation and the COBAS Amplicor Analyzer.

Use:

The Tecan Clinical Workstation is a multiple-task instrument used in clinical laboratories for the detection of Chlamydia and gonorrhea. The COBAS GUI software allows an operator to communicate between the Tecan Workstation and the COBAS Amplicor Analyzer.

Recalling Firm:

Roche Diagnostics Corporation
9115 Hague Road
Indianapolis, IN 46256-1025

Reason for Recall:

A software error in the COBAS GUI software may assign sample results to the wrong patient without notification to the equipment operator of a problem 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 on this product recall, see the FDA Enforcement Report.