Roche Molecular Systems, Inc. Recall: Amplilink (AL) Software 3.2.3 for use with COBAS AMP
Roche Molecular Systems, Inc. Recall: Amplilink (AL) Software 3.2.3 for use with COBAS AMP is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Roche Molecular Systems, Inc.; Product: Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS T
| Recalling firm | Roche Molecular Systems, Inc. |
|---|---|
| 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. |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide (USA) Distribution |
| Recall initiated | 20120423 |
| Recall number | Z-2403-2012 |
| Category | device |
| State | NJ |
| Country | United States |
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