DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro… recallZ-1546-2024 · Beckman Coulter, Inc. · initiated Mar 5, 2024

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

Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.

FDA root cause category: Process control

What the company is doing

Beckman Coulter notified consignees on 03/05/2024 via FedEx and email. The letter outlined the reason for the recall and requested consignees to review inventory for affected units. If any affected units are identified, to inspect the area underneath the wash buffer drawer for evidence of leaking wash buffer. If leaking or pooling is observed, clean up liquid wearing appropriate Personal Protective Equipment (PPE), discontinue the use of the DxI 9000, and contact your Beckman Coulter representative immediately. If no leaking or pooling of Wash Buffer in observed, continue operating the instrument as normal and continue to monitor for leaking. A Field Service Representative will contact customers to replace the internal wash buffer tank on the affected instruments. Consignees were also instructed to share this information with laboratory staff, notify any customers if further distributed, and complete and return the response form.

Recall details

Recall number: Z-1546-2024
Status: Open, Classified
Initiated by the company: Mar 5, 2024
Posted by the FDA: Aug 30, 2024
Recalling firm: Beckman Coulter, Inc.
Quantity: 17 units
Product code: JJE
FDA submissions: K221225
Distribution: Worldwide - US Nationwide distribution in the state of New Hampshire and the countries of Belgium, Egypt, Italy, Poland, Spain.

Product description

DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Code information (models, lots, serial numbers)

UDI/DI 15099590732103, Serial Numbers: 300254, 300256, 300257, 300258, 300259, 300263, 300264, 300266, 300268, 300269, 300270, 300271, 300272, 300273, 300275, 300281, and 300282

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 C11137
Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
17 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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