DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative,

FDA device recall Z-1546-2024 · posted 2024-08-30 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

JJE

Quantity affected

17 units

Distribution

Worldwide - US Nationwide distribution in the state of New Hampshire and the countries of Belgium, Egypt, Italy, Poland, Spain.

Date initiated

2024-03-05

Date posted

2024-08-30

Location

Chaska, MN

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