Device product
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Z-1346-2013
Product summary
- Event
- Event 64930
- Status
- Terminated
- Classification
- Class II
- Quantity
- 425 instruments
- Official record key
device-enforcement:Z-1346-2013
Official wording
Reason: In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the cobas¿ 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported
Code information: Material Number 05200881001 - all lot/serial numbers.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the cobas¿ 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported