Hematology Analyzer May Produce Falsely Elevated Hemoglobin Results
Beckman Coulter's UniCel DxH 600 hematology analyzers may report falsely high hemoglobin levels in samples with elevated white blood cell counts, potentially leading to clinical misdiagnosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device capable of producing erroneous diagnostic results. The device can report falsely elevated hemoglobin levels, which constitute a risk of clinical harm through diagnostic error. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm medical devices without reported injury are rated at level 3 (High).
Plain-English summary
Beckman Coulter is recalling the UniCel DxH 600 COULTER Cellular Analysis System configured with an LED HGB photometer (Reference B23858). The device may report erroneously high hemoglobin levels in samples with elevated white blood cell counts.
Falsely elevated hemoglobin results could cause clinicians to underestimate anemia severity or make incorrect treatment decisions based on inaccurate laboratory values.
The affected device has been distributed worldwide to clinical laboratories. Specific serial numbers are identified in the official FDA recall notice.
Organizations using affected units should contact Beckman Coulter regarding the recall. Existing hemoglobin test results, particularly from samples with elevated white blood cell counts, may require review to ensure accurate patient care.
The recalled product
- Product
- UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- measurement-error
- false-positive-hemoglobin
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- UDI: 15099590192242/ Serial Numbers: AV52143
- AZ02628
- AZ06676
- AZ24836
- BA07048
- BA08667
- BA17727
- BA31855
- BB10648
- BB49881
- BC24713
Distribution
Distributed nationwide across the United States.
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