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U.S. Department of Health and Human Services

Medical Devices

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Roche Diagnostics Tecan Clinical Workstation (3/5/04)

Class 1 Recall

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.