Z-1388-2025 Class II Ongoing
FDA device recall Z-1388-2025 was initiated by Beckman Coulter, Inc. on February 5, 2025 and is designated Class II. Reason for recall: 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 resu… The recall status is ongoing. Affected quantity: 206 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2025
- Initiation Date
- February 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 206 units
Product Description
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Reason for Recall
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.
Distribution Pattern
US Nationwide. Global Distribution.
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