Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with specific firmware versions that may cause delays in patient result reporting. Affected units include those with PCB, TSI/RSI firmware C29278 and catalog number C11137.
Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.
Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzers due to a firmware issue that can cause delays in reporting patient results. This means lab users might get incorrect or delayed test results if they use the affected units.
The DxI 9000 analyzer has a firmware version that can cause communication failures between the tip stocker interface (TSI) and reagent storage interface (RSI) boards. This leads to delays in reporting patient results, but does not cause physical harm or equipment damage.
Lab users with the specific firmware version and catalog number C11137 are affected. The risk is low as the issue only causes delays in reporting, not immediate safety hazards.
Check if your DxI 9000 analyzer has the catalog number C11137 and firmware version C29278. The serial numbers listed in the recall notice include specific numbers like 300158, 300161, and others.
Verify your DxI 9000 analyzer's firmware version by checking the PCB, TSI/RSI firmware number. If it matches C29278, it is affected.
The affected firmware version is C29278 for the TSI/RSI boards.
Check if your analyzer has catalog number C11137 and firmware version C29278. The serial numbers listed in the recall include specific numbers like 300158, 300161, and others.
The recall does not specify a remedy, so contact Beckman Coulter directly for further instructions.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1387-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1387-2025 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.
