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Recall Observatory FDA recall evidence

Device product

Beckman Coulter DxI 9000 Access Immunoassay Analyzer

Z-1664-2025

March 27, 2025

Class II

Product summary

Firm
Beckman Coulter, Inc.
Event
Event 96554
Status
Ongoing
Classification
Class II
Quantity
370 units
Official record key
device-enforcement:Z-1664-2025

Official wording

Reason: 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.

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

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.