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Roche Molecular Systems, Inc. recalls Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The so
Recalled September 26, 2012 · FDA recall Z-2403-2012 · Roche Molecular Systems
Hazard
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 Class II
Units
1292 instruments
Sold at
Nationwide (USA) Distribution
Description
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.
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.
Manufacturer(s)
Roche Molecular Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →