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U.S. Department of Health and Human Services

Class 2 Device Recall Roche

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 Class 2 Recall
Roche
see related information
Date Posted January 31, 2013
Recall Status1 Open
Recall Number Z-0762-2013
Recall Event ID 63997
Product Classification System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex - Product Code MWA
Product COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
Code Information 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.
Recalling Firm/
Manufacturer
Roche Molecular Systems, Inc.
1080 Us Highway 202 S
Branchburg, New Jersey 08876-3733
For Additional Information Contact Mr. Vincent Stagnitto
908-253-7569
Manufacturer 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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the 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: rmdsafeb@roche.com) once actions in FSN are executed.
Quantity in Commerce 335 CE-IVD TDFs; 48 JPN-IVD TDFs
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)
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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