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U.S. Department of Health and Human Services

Class 2 Device Recall AMPLILINK Software, version 3.1.0 to 3.2.2

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 Class 2 Recall
AMPLILINK Software, version 3.1.0 to 3.2.2
see related information
Date Posted August 27, 2009
Recall Status1 Terminated on August 13, 2010
Recall Number Z-1928-2009
Recall Event ID 52118
Product Classification Clinical Sample Concentrator - Product Code JJH
Product AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS AmpliPrep/COBAS TaqMan is capable of tunning HBV, HCV, and HIV tests.
Code Information Version 3.1.0, Version 3.1.1, Version 3.1.2, Version 3.2.0, Version 3.2.1, and Version 3.2.2.
Recalling Firm/
Manufacturer
Roche Molecular Systems, Inc.
1080 US Highway 202 S
Somerville, New Jersey 08876-3733
For Additional Information Contact Vincent Stagnitto
908-253-7569
Manufacturer Reason
for Recall
Software bug: A unique series of events involving the COBAS AmpliPrep instrument running AMPLILINK software version 3.2.2 that results in specimens being amplified and detected with the wrong parameters. The error can occur on either COBAS AmpliPrep/COBAS TaqMan 48, COBAS AmpliPrep/COBAS TaqMan (docked) or cobas s 201 system (docked) running Amplilink Software versions 3.1 or 3.2 series up to and
FDA Determined
Cause 2
DESIGN: Software Design
Action Urgent Medical Device Correction Letters were sent on June 2, 2009 by first class mail. The letter described the issue; impact on results; clinical implications; the workaround; and the actions required, which include following the workaround until a new version of AMPLILINK software is available and filing the letter for future reference. Questions or concerns should be directed to Roche Diagnostics Technical Support at 1-800-526-1247.
Quantity in Commerce 282
Distribution Nationwide Distribution
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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