Hematology Analyzer May Produce Erroneously High Hemoglobin Results
Beckman Coulter's UniCel DxH 800 hematology analyzer may produce incorrect hemoglobin measurements on samples with high white blood cell counts. Inaccurate results could lead 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 Class II medical device recall presents a risk-of-harm through measurement error that could lead to clinical misdiagnosis. No illnesses or injuries have been reported. This meets the rubric criterion for score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
The UniCel DxH 800 COULTER Cellular Analysis System, when configured with the Led HGB Photometer, is subject to a Class II recall. The analyzer may produce erroneously high hemoglobin results on blood samples with elevated white blood cell counts.
This measurement error could lead to misdiagnosis and inappropriate clinical decisions. The hazard is specific to samples with high WBC counts and does not affect all testing.
The affected devices have been distributed worldwide, including across the United States. Affected serial numbers and UDI numbers are identified in the original FDA notice.
Healthcare facilities and laboratories should contact Beckman Coulter Inc. for remediation guidance or replacement of affected units. Clinical staff should be aware of potential measurement errors when analyzing samples with elevated WBC counts.
The recalled product
- Product
- UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- measurement-error
- lab-result-inaccuracy
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 (20)
- UDIs: 15099590672423
- 15099590381646
- 15099590687922/ Serial Numbers: AT38527
- AU02008
- AU10078
- AV28630
- AW13187
- AW29123
- BC18100
- RBB03201
- AW43276
- AY06074
- AY06092
- AY41556
- AY43605
- AZ02030
- AZ03041
- AZ18245
- AZ22329
- AZ39513
Distribution
Distributed nationwide across the United States.
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