Device product
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.
Z-0484-2013
Product summary
- Event
- Event 63312
- Status
- Terminated
- Classification
- Class II
- Quantity
- 884 units
- Official record key
device-enforcement:Z-0484-2013
Official wording
Reason: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Code information: Device-associated diagnostic software
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Device software or design
software issue