—#212435

Product

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K221225
Affected lot / 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

Why it was recalled

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.

Root cause (FDA determination)

Process design

Action the firm took

An URGENT MEDICAL DEVICE RECALL notification letter dated 1/30/25 was sent to customers. Affected DxI 9000 Access Immunoassay Analyzers could experience an increase in the following errors: IncubateWheel.Axis MachineControlStatus(Encoder reports that axis position is out of tolerance) WashWheel.Axis MachineControlStatus(Encoder reports that axis position is out of tolerance) This can cause the analyzer to enter the red, or Stopped, system status and any in-process tests are cancelled. There could be a delay in reporting patient test results to the physician. If the error occurs: 1. Confirm that the DxI 9000 Access Immunoassay Analyzer is in either the Paused or Stopped system state. 2. Select the System state button in the lower left corner of the user interface. 3. Select Initialize. When initialization is complete, the analyzer returns to the green, or Running, state. If your laboratory has experienced the issue and it is not resolved by initializing the analyzer, contact your Beckman Coulter representative and schedule a service visit. Beckman Coulter has identified the root cause of this issue and is no longer distributing affected motors for the Incubate and Wash Wheel assemblies. A Beckman Coulter service representative will schedule a visit to replace any affected motors on your DxI 9000 Access Immunoassay Analyzer. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support Center; From our website: http://www.beckmancoulter.com

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: US Nationwide. Global Distribution.

Timeline

Recall initiated: 2025-02-05
Posted by FDA: 2025-03-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212435. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.