Company:Roche Molecular Systems, Inc.
Date of Enforcement Report 2/6/2013
Class ll:
PRODUCT
COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. Recall Number Z-0762-2013
REASON
The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD and JPN-IVD, have an incorrect Target Elbow Max cutoff value of 48 creating the potential for false negative results to be generated for patient samples with Target Elbows in the range of 48 to 50.
RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc., Branchburg, NJ on 11/28/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
335 CE-IVD TDFs; 48 JPN-IVD TDFs
DISTRIBUTION
Nationwide and Internationally
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