Recall Z-2403-2012
Roche Molecular Systems, Inc. · initiated April 23, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 05666678001
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.
FDA-determined 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.
Details
- Recall number
- Z-2403-2012
- Initiated
- April 23, 2012
- Posted by FDA
- September 18, 2012
- Terminated
- February 12, 2014
- Quantity
- 1292 instruments
- Distribution
- Nationwide (USA) Distribution
- Recalling firm
- Roche Molecular Systems, Inc., S Branchburg, NJ