Date Recall Initiated: |
May 5, 2004 [See Also March 5, 2004 Recall
for Same Device] (purge problem) |
---|---|
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 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/ENF00854.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