Device product
Tosoh AIA-900 immunoassay Analyzer
Z-0485-2019
Product summary
- Event
- Event 81219
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-0485-2019
Official wording
Reason: A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result.
Code information: 10313605 10503612 10634103
Distribution pattern: Distributed to accounts in GA and NY.
Derived failure modes
-
Device software or design
software issue