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U.S. Department of Health and Human Services

Class 2 Device Recall Amplilink Software v3.2

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 Class 2 Recall
Amplilink Software v3.2
see related information
Date Posted September 18, 2012
Recall Status1 Terminated on February 12, 2014
Recall Number Z-2403-2012
Recall Event ID 62738
Product Classification Blood Establishment Computer Software, User Developed - Product Code OYT
Product Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
Code Information 05666678001
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
When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order.
FDA Determined
Cause 2
DESIGN: Device Design
Action Roche Molecular Systems Inc. sent "Urgent Field Safety Notice" letters and Faxback forms on 4/23/2012 via UPS to all affected customers. The issue was described and recommended actions were provided. A Product Advisory Notice and an Updated Field Safety Notice were issued as well.
Quantity in Commerce 1292 instruments
Distribution Nationwide (USA) 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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