Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with software versions 1.17.0 or below due to sample timeout errors that may delay patient treatment. Affected units have specific catalog numbers and UDI-DI codes.
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.
Beckman Coulter is recalling DxI 9000 Access Immunoassay Analyzers with software versions 1.17.0 or older. This issue can cause sample tests to be flagged as timeout errors, potentially delaying patient treatment if the analyzer runs out of sample capacity.
When the analyzer runs out of sample capacity, it doesn't alert the laboratory system. This causes the system to continue sending samples even though it can't process them, leading to timeout errors and potential delays in patient treatment.
Laboratory users with DxI 9000 Access Analyzers running software versions 1.17.0 or below are most at risk. This affects medical facilities that use the device for patient testing.
Check for the catalog number C11137 and software versions 1.17.0 or below. The device also has a specific UDI-DI code 15099590732103.
Install the latest software version to fix the timeout error issue.
Software versions 1.17.0 or below.
Check for catalog number C11137 and software versions 1.17.0 or below, or UDI-DI code 15099590732103.
Sample tests may be flagged with a sample wheel timeout error, potentially causing delays in patient treatment.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2735-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2735-2024 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
