Hematology Analyzers May Produce Erroneously High Hemoglobin Results
The UniCel DxH 690T hematology analyzer may produce erroneously high hemoglobin results when testing samples with elevated white blood cell counts. Incorrect readings could affect patient diagnosis and treatment decisions.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical but significant: erroneous laboratory results could affect clinical decision-making. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Beckman Coulter Inc. is recalling the UniCel DxH 690T COULTER Cellular Analysis System configured with the LED HGB Photometer. The recall, classified as FDA Class II, applies to units with specific serial numbers identified through the UDI code.
The affected hematology analyzers may produce erroneously high hemoglobin (HGB) results when analyzing samples with elevated white blood cell (WBC) counts. This measurement error occurs when a sample has a high WBC count that interferes with the hemoglobin testing process, causing artificially elevated hemoglobin values.
These units have been distributed worldwide, including throughout the United States and in numerous international locations such as Canada, Australia, Mexico, Europe, and Asia.
Users of affected systems should be aware of the potential for elevated hemoglobin readings when processing samples with high white blood cell counts. For information on corrective actions or system remediation, users should contact Beckman Coulter.
The recalled product
- Product
- UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- lab-measurement-error
- hemoglobin-false-elevation
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 (10)
- UDI: 15099590729110/ Serial Numbers: BD17734
- BE12048
- BE28105
- BF14045
- BF23096
- BF46236
- BG26135
- BG50247
- BH12019
- BH43168
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03
- HighPhilips Allura Imaging Systems Hard Drive Degradation Affects Functionality
FDA (Devices) · 2026-06-03