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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Product Detail

Product Description 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.
Recall Number Z-2403-2012
Classification Class II
Code Info 05666678001
Product Distributed Qty 1292 instruments
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.

Event Detail

Event Id 62738
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 2012-04-23
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide (USA) Distribution
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