Device product
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Z-1233-2016
Product summary
- Event
- Event 73292
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35 Units
- Official record key
device-enforcement:Z-1233-2016
Official wording
Reason: Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport (RTT) after the decapping process. Therefore, open sample tubes can be dropped in the cobas p 512, spilling the sample material.
Code information: Part numbers:05083435001 and 06268854001
Distribution pattern: US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
Derived failure modes
-
Unknown
Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport (RTT) after the decapping process. Therefore, open sample tubes can be dropped in the cobas p 512, spilling the sample material.