Beckman Coulter Hematology Analyzers Recalled for Potential Blast Detection Failure
Beckman Coulter is recalling LH 750, LH 780, and LH 500 analyzers because they may fail to flag blasts in some blood samples.
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: The recall involves a risk-of-harm product (medical diagnostic device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed adverse events.
Plain-English summary
Beckman Coulter Inc. is recalling the Coulter LH 750, LH 780, and LH 500 hematology analyzers. These devices are quantitative, automated hematology analyzers and leukocyte differential counters used in clinical laboratories for in vitro diagnostic purposes. The recall involves 6,763 units distributed worldwide, including the United States and numerous international locations.
The recall was initiated because Beckman Coulter determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the analyzers may not flag or detect blasts in some blood samples. This potential failure to detect blasts could impact the diagnostic process for patients requiring additional studies of specific parameters.
Clinical laboratories using these devices should contact Beckman Coulter for further instructions regarding the clarification of Blast Suspect messages and the handling of affected samples.
The recalled product
- Product
- Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 6,763
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 (12)
- Catalog Number(s): LH 750 System - 6605632
- A85570
- A68807
- LH 780 System - 723585
- A90728
- A68808
- LH 500 system - 6605525
- 6605526
- 6605527
- A85566
- A85564
- All software versions
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- High
Same hazard · mis diagnosis
See all →- SevereVolcano Corp Recalls Philips IntraSight Plus Systems Due to Data Error
FDA (Devices) · 2026-10-07
- HighBioporto ProNephro AKI Reagent Kit Recalled for Non-Validated Rework Process
FDA (Devices) · 2026-08-19
- HighFilmArray NGDS Warrior Panel Diagnostic Test Recalled Due to Strain Mismatch
FDA (Devices) · 2026-08-12
- HighDASH Rapid PCR Instrument Recalled Due to Software Issue Causing False Co-infection Results
FDA (Devices) · 2026-08-12
- HighDiagnostic Genetic Probe Recalled for Unexpected Chromosome Signals
FDA (Devices) · 2021-08-04
Similar recalls
- ModerateBeckman Coulter LH 750 and LH 780 Hematology Analyzers Recalled for Valve Failure
FDA (Devices) · 2013-11-06
- HighBeckman Coulter Recalls LH 750 Hematology Analyzers Due to Optical Degradation
FDA (Devices) · 2013-12-18
- ModerateBeckman Coulter Recalls LH 750 and LH 780 Hematology Systems
FDA (Devices) · 2013-12-18
- HighBeckman Coulter Recalls UniCel DxH 800 and DxH 600 Hematology Analyzers
FDA (Devices) · 2013-11-13
- HighBeckman Coulter Recalls UniCel DxH 800 Hematology Analyzers
FDA (Devices) · 2012-10-17
- HighBeckman Coulter DxH 600 Cellular Analysis System Recall for Blast Detection
FDA (Devices) · 2017-01-18