Beckman Coulter recalls UniCel DxH 800 hematology analyzers configured with HGB photometers that may give falsely high hemoglobin results when samples have elevated white blood cell counts. Affected units include specific model references and serial numbers.
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Beckman Coulter is recalling UniCel DxH 800 hematology analyzers with certain HGB photometers because they can produce inaccurate hemoglobin readings when samples have high white blood cell counts. This could lead to incorrect medical diagnoses if the device is used for blood testing.
The device may show higher hemoglobin levels than actual when samples contain elevated white blood cell counts. This can cause incorrect medical decisions if the test results are used for diagnosis or treatment.
Healthcare facilities using the UniCel DxH 800 system with the specified HGB photometers are most at risk. Patients receiving blood tests with these devices may get inaccurate hemoglobin results.
Check if your UniCel DxH 800 system has the HGB photometer with reference numbers B24802, 629029, or B63322. Affected units include specific serial numbers listed in the recall notice.
Verify if your UniCel DxH 800 system uses the HGB photometer with reference numbers B24802, 629029, or B63322.
The UniCel DxH 800 system with certain HGB photometers may produce falsely high hemoglobin results when samples have elevated white blood cell counts.
Check if your device has the specified HGB photometer reference numbers or serial numbers listed in the recall notice. No immediate action is required beyond verification.
The recall addresses potential inaccurate hemoglobin results, which could affect medical decisions. However, the device does not pose a direct risk of injury or death in normal use.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2574-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2574-2025 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.
