Roche Molecular Systems Inc COBAS TaqMan analyzer, Series 96; catalog number 8080216. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
COBAS TaqMan analyzer, Series 96; catalog number 8080216.
Brand
Roche Molecular Systems Inc
Lot Codes / Batch Numbers
All units with software versions TaqLink v 1.0 or TaqLink v 1.1.
Products Sold
All units with software versions TaqLink v 1.0 or TaqLink v 1.1.
Roche Molecular Systems Inc is recalling COBAS TaqMan analyzer, Series 96; catalog number 8080216. due to A false positive result may be reported.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A false positive result may be reported.
Recommended Action
Per FDA guidance
Each customer was informed of the recall by telephone on March 6, 2003. Customers were instructed to check each postiive result to see if the 'RFITOOLOW' flag was generated, and follow-up instructions were provided. A recall letter was also faxed and mailed to each customer on March 6, 2003.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026