Beckman Coulter DxI 9000 Access Immunoassay Analyzer recallZ-1664-2025 · Beckman Coulter, Inc. · initiated Mar 27, 2025
Open, Classified
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
When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.
FDA root cause category: Software design
What the company is doing
Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 03/27/2025 via USPS first class mail. The notice explained the issue with the device, impact to the patient, and provided a workaround until a software upgrade is available. If the consignee further distributed the affected device, they were directed to provide a copy of the notice to the recipient. For questions, contact Customer Support Center, from the website: http://www.beckmancoulter.com
Recall details
- Recall number
- Z-1664-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 27, 2025
- Posted by the FDA
- Apr 24, 2025
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 370 units
- Product code
- JJE
- FDA submissions
- K221225
- Distribution
- Worldwide distribution.
Product description
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Code information (models, lots, serial numbers)
UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below
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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