Beckman Coulter recalls UniCel DxH 900 analyzers with HGB photometers that may give falsely high hemoglobin results when samples have elevated white blood cell counts. Affected units have specific serial numbers and reference codes.
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 900 hematology analyzers configured with HGB photometers because they can produce inaccurate hemoglobin results when samples contain high white blood cell counts. This could lead to incorrect medical diagnoses if the device is used without proper calibration.
The device may show falsely high hemoglobin levels in blood samples that have elevated white blood cell counts. This happens because the HGB photometer configuration is not properly calibrated for certain blood types. Incorrect hemoglobin readings could lead to misdiagnosis of conditions like infections or blood disorders.
Healthcare professionals using the UniCel DxH 900 system with HGB photometers for blood tests. Patients receiving lab results from these devices may be at risk of incorrect diagnoses if the hemoglobin readings are inaccurate.
Check if your UniCel DxH 900 analyzer has the reference code C11478 and serial numbers listed in the recall notice. The device may have a unique identifier (UDI) starting with 15099590701574.
Verify your UniCel DxH 900 analyzer has the reference code C11478 and the listed serial numbers.
The UniCel DxH 900 analyzers configured with HGB photometers may produce falsely high hemoglobin results on blood samples with elevated white blood cell counts.
Check if your device has the reference code C11478 and the listed serial numbers. If it does, contact Beckman Coulter for further instructions.
No, this recall does not involve a risk of injury. The issue is with test accuracy, not physical safety.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2572-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2572-2025 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.
