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.
This recall has been terminated (originally issued September 18, 2012).
- Company
- Roche Molecular Systems, Inc.
- Recall Initiated
- April 23, 2012
- Posted
- September 18, 2012
- Terminated
- February 12, 2014
- Recall Number
- Z-2403-2012
- Quantity
- 1292 instruments
- Firm Location
- Branchburg, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide (USA) Distribution
Lot / Code Info
05666678001
Root Cause
Device Design
Action Taken
Roche Molecular Systems Inc. sent "Urgent Field Safety Notice" letters and Faxback forms on 4/23/2012 via UPS to all affected customers. The issue was described and recommended actions were provided. A Product Advisory Notice and an Updated Field Safety Notice were issued as well.
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