FDA Recall
Terminated
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.
Recall: Z-2403-2012
·
Initiated April 23, 2012
Recall
- Recall Number
- Z-2403-2012
- Event Number
- 62738
- Firm
- Roche Molecular Systems, Inc.
- FEI Number
- 2243471
- Product Code
- OYT
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- April 23, 2012
- Posted
- September 18, 2012
- Terminated
- February 12, 2014
- Address
- 1080 Us Highway 202 S, Branchburg, NJ, 08876-3733
Description
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
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.
Action
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.
Distribution
Nationwide (USA) Distribution
Quantity
1292 instruments