Beckman Coulter Recalls LH 750 and LH 780 Hematology Systems
Beckman Coulter is recalling LH 750 and LH 780 Hematology Systems because optical degradation may delay reporting results for specific 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 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential delay in reporting results due to optical degradation, which fits the criteria for a moderate severity recall involving a risk of harm without reported injury.
Plain-English summary
Beckman Coulter Inc. is recalling the LH 750 and LH 780 Hematology Systems. These devices are quantitative, automated hematology analyzers and leukocyte differential counters used for in vitro diagnostic purposes in clinical laboratories. The recall affects 1,961 units total, with 610 units distributed in the United States and the remainder distributed worldwide.
The recall is being conducted because optical degradation in the systems may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential, and/or reticulocytes. This issue may impact the timeliness of diagnostic data provided to clinical laboratories.
Clinical laboratories and healthcare facilities that have purchased or received these units should contact Beckman Coulter for instructions on how to address the issue. The source text does not specify a particular consumer action for the general public, as the products are intended for professional clinical use.
The recalled product
- Product
- Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH 780 Hematology Analyzer is a is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 780…
- Manufacturer
- Beckman Coulter Inc.
Distribution
Distributed nationwide across the United States.
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.
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