Device 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.
Z-2403-2012
Product summary
- Event
- Event 62738
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1292 instruments
- Official record key
device-enforcement:Z-2403-2012
Official wording
Reason: 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.
Code information: 05666678001
Distribution pattern: Nationwide (USA) Distribution
Derived failure modes
-
Unknown
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.