Recall Z-2403-2012 ยท OYT
Roche Molecular Systems, Inc.
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.
| Date | Sep 18, 2012 (initiated Apr 23, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 1292 instruments |
| Distribution | Nationwide (USA) Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.