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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