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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 Device Recall Amplilink Software v3.2 see related information
Date Initiated by Firm April 23, 2012
Date Posted September 18, 2012
Recall Status1 Terminated 3 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 NJ 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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