Date Recall Initiated: |
May 3, 2004 [See Also March 5, 2004 Recall
for Same Device] (purge problem) |
---|---|
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 Roche press release at: http://www.fda.gov/cdrh/oivd/letters/050704-roche.html. Also, for additional information on this product recall, see the FDA
Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2004/ENF00853.html.
Scroll down to "Recalls and Field Corrections: Devices –
Class I". |
Updated July 1, 2004
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