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U.S. Department of Health and Human Services

Medical Devices

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Tecan Clinical Workstation with RoboNet Software

Class I Recall
Date Recall
Initiated:

May 3, 2004

[See Also March 5, 2004 Recall for Same Device] (purge problem)
[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 RoboNet Software.
Use:
The Tecan Clinical Workstation is a multiple-task instrument used in clinical laboratories for the detection of Chlamydia, gonorrhea and other tests. An operator controls the Tecan Clinical Workstation with an attached personal computer running the RoboNet software for data management.
Recalling Firm:
Tecan US Inc.
4022 Stirrup Creek Road, Suite 310
Durham, N.C. 27709
Reason for Recall:
An error in the RoboNet software may assign sample results to the wrong patient identification number resulting in false positive and false negative results. The software failure affects Chlamydia and gonorrhea testing using the Roche Tecan Clinical Workstation. Additionally, other test systems using the Tecan Clinical Workstation with RoboNet software may also be affected.
Public Contact:
Ron Wheeler
Quality Assurance Manager
800-352-5128
FDA District:
Atlanta
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 FDA Enforcement Report.