Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The so
FDA device recall Z-2403-2012 · posted 2012-09-18 · Terminated
Recall details
- Recalling firm
- Roche Molecular Systems, Inc.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OYT
- Quantity affected
- 1292 instruments
- Distribution
- Nationwide (USA) Distribution
- Date initiated
- 2012-04-23
- Date posted
- 2012-09-18
- Date terminated
- 2014-02-12
- Location
- S Branchburg, NJ
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