Hematology Analyzer May Report Falsely High Hemoglobin Levels
Beckman Coulter hematology analyzers may report erroneously high hemoglobin results in samples with elevated white blood cell counts, potentially affecting patient diagnoses.
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 recall without any reported illnesses, injuries, or deaths documented in the source text. The hazard—measurement inaccuracy—is a risk of potential harm to patients, but no actual clinical harm has been reported. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Beckman Coulter Inc. has recalled certain UniCel DxH 900 COULTER Cellular Analysis Systems configured with Led HGB Photometer (REF: C11478). Affected units are identified by UDI 15099590701574 and specific serial numbers listed in the recall notice.
Hematology analyzers configured with HGB photometers may produce erroneously high hemoglobin (HGB) results when analyzing samples with elevated white blood cell (WBC) counts. This measurement error could result in incorrect interpretation of patient test results and potentially affect clinical decision-making.
The recalled devices were distributed worldwide, including across all 50 U.S. states and territories and over 60 countries. Healthcare facilities, clinical laboratories, and diagnostic centers using affected analyzers should verify their equipment serial numbers against the recall list. If you operate an affected device, contact Beckman Coulter Inc. for guidance on corrective measures.
The recalled product
- Product
- UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- measurement-error
- hemoglobin-inaccuracy
- elevated-wbc-interference
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)
- UDI: 15099590701574/ Serial Numbers: BB33238
- BB33239
- BB42317
- BC05150
- BC08198
- BC10226
- BC16320
- BC21392
- BC23453
- BC25457
- BC25465
- BC30527
- BC32542
- BC42721
- BC42726
- BC49882
- BD13219
- BD41570
- BD46639
- BD46643
Distribution
Distributed nationwide across the United States.
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