Beckman Coulter, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1664-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Beckman Coulter DxI 9000 Access Immunoassay Analyzer

Product Classification:

Class II

Date Initiated: March 27, 2025

Date Posted: April 30, 2025

Recall Number: Z-1664-2025

Event ID: 96554

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.

Status: Ongoing

Product Quantity: 370 units

Code Information:

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

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated