COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
This recall has been terminated (originally issued January 31, 2013).
- Company
- Roche Molecular Systems, Inc.
- Recall Initiated
- November 28, 2012
- Posted
- January 31, 2013
- Terminated
- August 6, 2015
- Recall Number
- Z-0762-2013
- Quantity
- 335 CE-IVD TDFs; 48 JPN-IVD TDFs
- Firm Location
- Branchburg, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - Foreign (22 EU countries - Austria, Belgium, Bulgaria, Croatia, Cypress, Czech Republic, Denmark, Germany, Finland, France, Greenland, Hungary, Iceland, Italy, Luxembourg, Netherland, Norway, Sweden, Switzerland, Spain, Turkey, UK); (41 Rest of World countries - See Attachment for full country distribution + Japan, Portugal and Mexico)
Lot / Code Info
Material Number: CE-IVD: 04803531190 Kit, 05574455190 TDF; JPN-IVD: 04653360190 Kit, 05574447190 TDF. Lot/Serial Number: CE-IVD: All Kits, JPN-IVD: All Kits.
Root Cause
Component change control
Action Taken
Roche issued Product Advisory Notice (PAN) 2012-11 and Urgent Field Safety Notice PAN 2012-11 by email to Local Safety Officers (LSO) and General/Country Managers from all countries on 28-Nov-2012. The notice identifed the affected product, problem and actions to be taken. LSOs are to provide the information in the Field Safety Notice (FSN) to each customer and return a Feedback Form to Roche (email address: rmdsafeb@roche.com) once actions in FSN are executed.