COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
FDA Recall Z-0762-2013 · Posted 2013-01-31
Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeMWA
Date Initiated2012-11-28
Date Terminated2015-08-06
Product Quantity335 CE-IVD TDFs; 48 JPN-IVD TDFs
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.
Firm Action
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: [email protected]) once actions in FSN are executed.
Root Cause
Component change control
Distribution Pattern
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)
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.