Device product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Z-1388-2025
Product summary
- Event
- Event 96256
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 206 units
- Official record key
device-enforcement:Z-1388-2025
Official wording
Reason: the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.
Code information: UDI-DI: 15099590732103; Serial Numbers: 300116-300117, 300123-300124, 300126, 300128-300139, 300141-300145, 300147- 300158, 300160-300164, 300166-300179, 300181-300183, 300186, 300188-300195, 300197-300207, 300209-300250, 300252- 300256, 300258-300259, 300261, 300263- 300264, 300266-300277, 300279-300290, 300291, 300293-300299, 300300-300309, 300312-300352
Distribution pattern: US Nationwide. Global Distribution.
Derived failure modes
-
Unknown
the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.