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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Event Detail

Event ID 63997
Product Type Devices
Status Ongoing
Recalling Firm Roche Molecular Systems, Inc.
City Branchburg
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-28
Initial Firm Notification of
Consignee or Public
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)

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. 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. Class II 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. 335 CE-IVD TDFs; 48 JPN-IVD TDFs Z-0762-2013