Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with undersized pneumatic tubing that may cause air leaks and sample processing errors. Four complaints led to this recall.
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four complaints were filed for this event that led to Beckman Coulter finding undersized tubing in stock and initiated corrective actions. Use of the affected device may result in errors leading to delay of results.
Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzers due to undersized pneumatic tubing that can cause air leaks, compressor failures, or sample processing errors. This may delay test results and lead to inaccurate results.
The undersized pneumatic tubing in the reagent storage module can cause air leaks, which may lead to compressor failures or sample processing errors. This can result in delayed test results and inaccurate diagnostic outcomes.
Users of the recalled DxI 9000 Access Immunoassay Analyzers with specific serial numbers are affected. Laboratory staff and healthcare professionals who use these devices for diagnostic testing are most at risk.
Check for the model number C21510 and the specific serial numbers listed in the recall notice. The affected units were sold with the RSM Pneumatic Tubing Kit item #2.
Inspect the reagent storage module for signs of air leaks or unusual noises that might indicate compressor issues.
Reach out to Beckman Coulter for guidance on corrective actions or potential replacements for the affected units.
Beckman Coulter is recalling these analyzers due to undersized pneumatic tubing that can cause air leaks, compressor failures, or sample processing errors, which may lead to delayed test results.
Check if your device has model number C21510 and one of the specific serial numbers listed in the recall notice.
Contact Beckman Coulter directly for guidance on corrective actions or potential replacements.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-3180-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-3180-2024 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.
