Beckman Coulter recalls UniCel Dxl 600 analyzers with specific part numbers that may not restart after shutdown, leading to delayed patient test results. Affected units require immediate action to prevent incomplete testing.
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
Beckman Coulter is recalling UniCel Dxl 600 analyzers with specific part numbers because they may not restart properly after shutdown, causing delayed test results. This means the equipment might not process patient samples, quality controls, or calibrators correctly.
The analyzers may fail to restart after a standard shutdown, even after multiple attempts. This prevents the instrument from completing initialization and transitioning to Ready mode, so it cannot process patient samples, quality controls, or calibrators. As a result, test results are delayed.
Laboratories using Beckman Coulter UniCel Dxl 600 analyzers with part numbers A71460, A71461, or A30260 are affected. Lab technicians and medical staff who rely on these analyzers for troponin subunit testing are most at risk.
Check for part numbers A71460, A71461, or A30260 on the analyzer. The UniCel Dxl 600 is used for troponin subunit immunoassay testing and was sold with specific unique device identifiers (UDIs).
Verify if the analyzer restarts properly after shutdown by attempting multiple restarts. If it fails to reach Ready mode, it may need adjustment.
Part numbers A71460, A71461, and A30260 are affected.
The analyzers may not restart properly after shutdown, causing delayed test results and preventing proper processing of patient samples, quality controls, or calibrators.
No immediate stop is required, but labs should check if the device restarts properly after shutdown to avoid delayed 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-1025-2026 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1025-2026 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.
