Roche COBAS TaqMan and TaqMan 48 Analyzers

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FDA and Roche Molecular Systems

FDA and Roche Molecular Systems notified healthcare professionals of a Class 1 recall of the Roche COBAS TaqMan and TaqMan 48 Analyzer, used for the measurement of hepatitis B and hepatitis C viruses and for other in-house diagnostic testing. The analyzers produced falsely elevated values due to the improper seating of a fiber optic cable in the analyzer instrument. FDA considers that the probability of life threatening consequences is likely to occur by the malfunctioning of these devices.

Read the MedWatch 2004 safety summary, including a link to the FDA recall notice:

Roche COBAS TaqMan and TaqMan 48 Analyzers

Roche COBAS TaqMan and TaqMan 48 Analyzers var addthis_options = 'facebook, digg, delicious, linkedin, twitter, more';var addthis_exclude = 'print'; |

Roche COBAS TaqMan and TaqMan 48 Analyzers

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