FDA Medical Device Recalls (openFDA)
Beckman Coulter, Inc.: DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
- Recall number
- Z-1388-2025
- Recalling firm
- Beckman Coulter, Inc.
- Product
- DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
- Status
- Open, Classified
- Initiated
- 2025-02-05
- Posted
- 2025-03-17
- Terminated
- not on file
- 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.
- Root cause
- Process design
- Action
- 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
- Quantity
- 206 units
- Distribution
- US Nationwide. Global Distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K221225"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 2122870
- Firm city
- Chaska
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28