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U.S. Department of Health and Human Services

Medical Devices

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Roche Molecular Systems COBAS TaqMan and TaqMan 48 Analyzers

Class I Recall
Date Recall
Initiated:
May 24, 2004
Product: Roche COBAS TaqMan and TaqMan 48 Analyzers.
Use: The COBAS TaqMan and TaqMan 48 analyzers are intended to be used by laboratory professionals. The analyzers are used for the measurement of Hepatitis B and Hepatitis C viruses and for other in-house diagnostic testing.
Recalling Firm:
Roche Molecular Systems, Inc.
11 Franklin Avenue
Belleville, N.J. 07109-3501
Reason for Recall:
The analyzers produced inaccurate test results. Falsely elevated values were reported due to the improper seating of a fiber optic cable in the analyzer instrument.
Public Contact:
Karen McCullough
Director, Quality Systems Compliance
Roche Molecular Systems, Inc.
908-253-7610
FDA District:
New Jersey
FDA Comment:
FDA considers that the probability of life threatening consequences is likely to occur by the malfunctioning of these devices. 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.
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