The Recall Desk
ModerateFDA (Devices)·Z-0113-2014·Announced 2013-11-06

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.

What this means for you

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 Reti
Affected units
1,697

Distribution

Distributed nationwide across the United States.