05

May

2004

Roche Diagnostics Corporation

0

Date Recall
Initiated: May 5, 2004

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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