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Beckman Coulter DxI 9000 Access Immunoassay Analyzer

FDA Recall #Z-1664-2025 — Class II — March 27, 2025

Recall #Z-1664-2025 Date: March 27, 2025 Classification: Class II Status: Ongoing

Product Description

Beckman Coulter DxI 9000 Access Immunoassay Analyzer

Reason for Recall

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.

Recalling Firm

Beckman Coulter, Inc. — Chaska, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

370 units

Distribution

Worldwide distribution.

Code Information

UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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