Beckman Coulter recalls DxFLEX Flow Cytometers with specific serial numbers due to a software error that may cause delayed patient results when running custom acquisition protocols.
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
Beckman Coulter is recalling DxFLEX Flow Cytometers with specific serial numbers because a software error can crash during patient sample analysis, potentially delaying critical test results.
The software error causes crashes when running customer-defined acquisition protocols on patient samples. This can lead to delayed patient results, which may impact timely diagnosis and treatment decisions.
Healthcare facilities using the DxFLEX Flow Cytometer for in vitro diagnostic testing are affected. Laboratory staff and patients who rely on timely results from this device are at risk.
Check the serial numbers listed: BH44060, BJ09004, BJ14015, BJ09010, BJ13012, BJ14014, BJ13011, BJ14017, BJ13013, BJ09003, BJ09008, BJ09009, BH39057, BH44059, BJ14016, BJ05002, BJ17020, BJ17021, BH26031, BJ19024, BJ09005, BJ09006, BJ09007, BJ19022, BJ19023. The device is intended for use in medical labs for immunophenotyping.
Verify if your DxFLEX Flow Cytometer has a serial number from the list provided in the recall notice.
The recall is due to a software error that can crash during patient sample analysis when running customer-defined acquisition protocols, potentially delaying patient results.
Check if your device has a serial number from the list provided in the recall notice. If it does, contact Beckman Coulter for further instructions.
The recall does not mention any risk of serious injury; the hazard is limited to potential delays in patient results.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0541-2026 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0541-2026 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.
