FDA Device

COBAS TaqMan analyzer, Series 96; catalog number 8080216.

Hazard

A false positive result may be reported.

What You Should Do

Remedy

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.

Products

COBAS TaqMan analyzer, Series 96; catalog number 8080216.
Brand
Roche Molecular Systems Inc
UPC
All units with software versions TaqLink v 1.0 or TaqLink v 1.1.

Units Affected

16