Device product
Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.
Z-0297-2016
Product summary
- Event
- Event 72427
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0297-2016
Official wording
Reason: Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.
Code information: During transport from the Bulk Loader Module (BLM), catalog number 07135645001, to the cobas p 512/p 612 pre-analytical instruments, sample tubes may inadvertently open and spill, causing contamination of the system.
Distribution pattern: Distributed to TX only.
Derived failure modes
-
Unknown
Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.