Beckman Coulter LH 750 and LH 780 Hematology Analyzers Recalled for Valve Failure
Beckman Coulter is recalling LH 750 and LH 780 hematology analyzers because check valves may fail, causing air or liquid leaks.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes a mechanical defect (valve failure) leading to leaks but does not report any injuries, illnesses, or deaths, nor does it describe a high-risk pathogen or structural vehicle defect, placing it in the Moderate category.
Plain-English summary
Beckman Coulter Inc. is recalling the Coulter LH 750 and LH 780 Hematology Analyzers. These devices are quantitative, automated hematology analyzers and leukocyte differential counters intended for in vitro diagnostic use in clinical laboratories.
The recall is due to a potential failure of the check valves on the analyzers. If the check valves fail, it may result in an air or liquid leak at the connection to the Vacuum Overflow Tank waste line or at the Backwash Tank drain line.
The affected units were distributed worldwide, including nationwide distribution in the United States and in Canada. A total of 1,697 units are included in this recall. Users should contact Beckman Coulter Inc. for instructions on how to address the defect.
The recalled product
- Product
- COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 1,697
Distribution
Distributed nationwide across the United States.
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