Beckman Coulter recalls Access 2 Immunoassay Analyzers with specific serial numbers due to a motor alignment issue that could delay patient test results. Affected units have a worn production tool causing sample motor misalignment.
Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results.
Beckman Coulter is recalling Access 2 Immunoassay Analyzers with certain serial numbers because a production tool issue caused sample motors to rub against the sample wheelbase plate. This could delay patient test results but does not cause immediate injury or damage.
The issue stems from a worn tool used in production that caused improper alignment of the sample motors. This misalignment leads to the motors rubbing against the sample wheelbase plate and index sensor, which can delay patient test results.
Healthcare facilities that own or use the Access 2 Immunoassay Analyzer with the listed serial numbers are most at risk. Patients using these analyzers for lab testing may experience delayed results.
Check if your Access 2 Immunoassay Analyzer has the catalog number 81600N and the listed serial numbers (574626 through 574999, with specific numbers provided in the recall).
Verify your Access 2 Immunoassay Analyzer's serial number against the list of affected numbers provided in the recall.
Beckman Coulter identified that an issue with the Access 2 Sample Motors (B48016) due to improper alignment caused the motors to rub against the sample wheelbase plate and index sensor. This was traced to a worn tool used in production at the supplier.
No injuries have been reported, and the hazard only affects test result timing, not physical safety.
Check your serial number against the list provided in the recall. If affected, contact Beckman Coulter 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-1386-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1386-2025 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.
