Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DxI 9000 Access Immunoassay Analyzer Recalled by Beckman Coulter, Inc. Due to When a DxI 9000 Access Immunoassay Analyzer is...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter, Inc. directly.
Affected Products
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Quantity: 183 analyzers
Why Was This Recalled?
When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Beckman Coulter, Inc.
Beckman Coulter, Inc. has 79 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report