DxH 800 hematology analyzers recalled over erroneously high hemoglobin results
UniCel DxH 800 Coulter Cellular Analysis Systems configured with the LED HGB photometer are recalled because they may produce erroneously high hemoglobin results on samples with elevated white blood cell counts.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice states the analyzer can produce erroneously high patient results and no injuries are reported.
Plain-English summary
The UniCel DxH 800 COULTER Cellular Analysis System configured with the LED HGB Photometer, REFs B24802, 629029 and B63322, with UDIs 15099590672423, 15099590381646 and 15099590687922, is being recalled. Affected serial numbers include AT38527, AU02008, AU10078, AV28630 and AW13, with the full list in the recall notice. Distribution was nationwide in the United States and internationally.
Hematology analyzers configured with HGB photometers may produce erroneously high hemoglobin results on samples with elevated white blood cell counts. The FDA classified the action as Class II.
Laboratories operating these analyzers should follow the manufacturer's instructions, including any guidance on reviewing results already reported.
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.
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
Part of a larger recall action
This product is one of 4 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- HighBeckman Coulter Optima Ultracentrifuge Rotors Recalled for Structural Defect
FDA (Devices) · 2026-10-28
- SevereBeckman Coulter Centrifuge Rotors Recalled for Structural Defect
FDA (Devices) · 2026-10-28
- SevereBeckman Coulter DxU 840m and 850m Iris Recalled for Check Valve Defect
FDA (Devices) · 2026-10-21
- SevereBeckman Coulter IQ200 Hematology Analyzers Recalled for Check Valve Defect
FDA (Devices) · 2026-10-21
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
Same hazard · erroneous results
See all →- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighChemistry analyzer control modules recalled over software that may give erroneous results
FDA (Devices) · 2025-12-24
- HighLaboratory automation recalled over unlabelled or mismatched secondary sample tubes
FDA (Devices) · 2025-12-03
- HighBlood lead test kits recalled over mislabeled calibration buttons
FDA (Devices) · 2025-12-03
- HighLaboratory automation recalled over sample tubes with mismatched labels
FDA (Devices) · 2025-12-03
Similar recalls
- SevereBeckman Coulter UniCel DxH 800 Hematology Analyzer Recall for Platelet Errors
FDA (Devices) · 2019-05-29
- SevereBeckman Coulter UniCel DxH 900 Hematology Analyzer Recall for Platelet Errors
FDA (Devices) · 2019-05-29
- HighBeckman Coulter UniCel DxH 800 Recalled for Potential Data Errors
FDA (Devices) · 2017-05-31
- SevereBeckman Coulter Recalls UniCel DxH 600 Hematology Analyzers for Platelet Errors
FDA (Devices) · 2019-05-29
- HighBeckman Coulter Recalls UniCel DxH 800 and DxH 600 Analysis Systems
FDA (Devices) · 2014-07-02
- HighBeckman Coulter Recalls UniCel DxH 800 Hematology Analyzers
FDA (Devices) · 2012-10-17