Reported Apr 30, 2025 · Ongoing
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 1000 Lake Hazeltine Dr · Chaska, MN · 55318-1037
Is this the product you have?
- Beckman Coulter DxI 9000 Access Immunoassay Analyzer
- Lot codes and dates
- UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below
- Amount recalled
- 370 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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