Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with software versions 1.17 and below that may cause delayed patient test results due to error messages when connected to lab systems.
The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.
Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzers that may show error messages when connected to lab systems, potentially delaying patient test results. This affects lab equipment used in medical testing environments.
When the analyzer connects to a lab automation system with outdated software, it sends error messages that may delay patient test results. This could impact timely treatment decisions but does not cause immediate injury.
Laboratories using Beckman Coulter DxI 9000 Access Immunoassay Analyzers with software versions 1.17 and below are most at risk. This affects medical testing facilities that rely on these analyzers for patient test processing.
Check if your analyzer has software version 1.17 or older. The product includes catalog number C11137 and UDI-DI 15099590732103.
Check if your analyzer has software version 1.17 or older and update to a newer version if available.
Beckman Coulter found that outdated software versions cause error messages when connected to lab systems, potentially delaying patient test results.
Software versions 1.17 and below are affected.
Check if your analyzer has software version 1.17 or older, and look for catalog number C11137 and UDI-DI 15099590732103.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2544-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2544-2024 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.
