Beckman Coulter recalls Access 2 Immunoassay System Analyzers with misaligned index wheels that cause reagent errors and delayed patient results.
Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed within the reagent carousel module. Customers affected by this issue may observe an increase in reagent carousel motion errors or QSMC errors that occur while unloading or loading reagent packs during system initialization and sample processing, which causes a non-operational system status and cancels tests; and patient results may be delayed if these errors cancel test processing.
Beckman Coulter is recalling Access 2 Immunoassay System Analyzers that may have misaligned index wheels causing reagent carousel errors. This can lead to canceled tests and delayed patient results if the system fails during sample processing.
The reagent carousel module has misaligned index wheels that cause errors when unloading or loading reagent packs. This leads to canceled tests during system initialization and sample processing, potentially delaying patient results.
Lab users who own or operate Access 2 Immunoassay System Analyzers with specific serial numbers listed in the recall notice. Patients whose tests are affected by system errors may experience delayed results.
Check if your Access 2 Immunoassay System Analyzer has a serial number listed in the provided range (e.g., 574415, 574440, 574484). The product is used for clinical testing in laboratories.
Verify if your analyzer has a serial number from the list provided in the recall notice.
Beckman Coulter identified a rise in reagent carousel motion errors caused by misaligned index wheels in the reagent carousel module.
The system may cancel tests during initialization and sample processing, leading to delayed patient results.
Check if your analyzer has a serial number listed in the provided range (e.g., 574415, 574440, 574484).
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2545-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2545-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
