Date Recall Initiated: |
March 5, 2004 [See Also May 3, 2004 Recall
for Same Device] (RoboNet software) |
---|---|
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 at: http://www.fda.gov/cdrh/oivd/letters/050704-roche.html. |
Updated June 18, 2004
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