Beckman Coulter DxI 9000 Access Immunoassay Analyzer… recallZ-1115-2025 · Beckman Coulter, Inc. · initiated Jan 3, 2024
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
FDA root cause category: Software design
What the company is doing
A field service engineer was dispatched to the customer site to perform the software update and to replace the PCB TSI-RSI board from 01/03/2024 through 12/26/2024.
Recall details
- Recall number
- Z-1115-2025
- Status
- Completed
- Initiated by the company
- Jan 3, 2024
- Posted by the FDA
- Feb 6, 2025
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 61 units
- Product code
- JJE
- FDA submissions
- K221225
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brazil, Croatia, France, Germany, Hungary, India, Ireland, Italy, New Zealand, Portugal, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland.
Product description
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Code information (models, lots, serial numbers)
UDI/DI 15099590732103, serial numbers: 300208, 300201, 300184, 300185, 300169, 300225, 300175, 300172, 300221, 300209, 300211, 300212, 300213, 300214, 300215, 300210, 300174, 300226, 300204, 300216, 300217, 300170, 300220, 300176, 300188, 300199, 300200, 300177, 300222, 300224, 300173, 300181, 300202, 300191, 300223, 300171, 300186, 300190, 300203, 300178, 300195, 300189, 300198, 300227, 300228, 300168, 300194, 300205, 300206, 300207, 300197, 300218, 300179, 300182, 300192, 300219, 300193, 300183, 300180, 300187, 300196.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DxI 9000 Access Immunoassay Analyzer C11137Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use17 recalls1 death3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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