Beckman Coulter UniCel DxH800 Automated Hematology Analyzer Recall
Beckman Coulter is recalling 15 UniCel DxH800 automated hematology analyzers because the Single-Tube Station shield may interfere with sample aspiration.
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, and the source text describes a mechanical interference issue without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling 15 units of the UniCel DxH800 automated hematology analyzer, part numbers 629029 and B24802. The recall involves specific serial numbers listed in the agency documentation.
The recall was initiated because the shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position. This defect could potentially affect the accuracy of the automated hematology analysis.
The affected units were distributed to locations in California, Arkansas, Hawaii, Ohio, Washington, Maryland, Canada, and Japan. Users of these devices should contact Beckman Coulter Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 15
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 (14)
- Serial Numbers: B24802: AW10161
- AW10154
- AZ34449
- AZ34447 629029: AT40563
- AT06096
- AT06095
- AT02044
- AW05080
- AW05072
- AW05066
- AT50679
- AS49422
- AS36312
- AS23151
Distribution
Part of a larger recall action
This product is one of 3 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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