Recall Z-0762-2013— Roche Molecular Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2012-11-28, terminated 2015-08-06. FDA's recall record names no specific 510(k) clearance for this event. Product: COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.. 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
- Roche Molecular Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-28
- Terminated
- 2015-08-06
- Firm location
- Branchburg, NJ, United States
Product description
COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.