FDA Enforcement
Class II
Ongoing
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Recall: Z-1388-2025
·
Reported March 26, 2025
Enforcement
- Recall Number
- Z-1388-2025
- Event ID
- 96256
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Beckman Coulter, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 26, 2025
- Initiation Date
- February 5, 2025
- Classification Date
- March 17, 2025
- Address
- 1000 Lake Hazeltine Dr, N/A, Chaska, MN, 55318-1037, United States
Description
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
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 Info
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
US Nationwide. Global Distribution.
Quantity
206 units