Roche Molecular Systems COBAS TaqMan and TaqMan 48 Analyzers

Audience: Clinical laboratory specialists and healthcare professionals

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.

[July 22, 2004 - Recall Notice - FDA]