FDA-Device2012-09-26Class II
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.
Roche Molecular Systems, Inc.
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.
Sold states
Nationwide (USA) Distribution
Affected count
1292 instruments
Manufactured in
1080 Us Highway 202 S, Branchburg, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2403-2012Don't want to check this manually?
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