Beckman Coulter, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1388-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

Product Classification:

Class II

Date Initiated: February 5, 2025

Date Posted: March 26, 2025

Recall Number: Z-1388-2025

Event ID: 96256

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.

Status: Ongoing

Product Quantity: 206 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated