Recall Z-2403-2012— Roche Molecular Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2012-04-23, terminated 2014-02-12. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Roche Molecular Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-04-23
- Terminated
- 2014-02-12
- Firm location
- Branchburg, NJ, United States
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.