Beckman Coulter UniCel DxH Slidemaker Stainer Recall for Sample Aspiration Interference
Beckman Coulter is recalling three units of the UniCel DxH Slidemaker Stainer because the 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, but the source text does not report any hospitalizations, injuries, or illnesses, and the hazard is a mechanical interference rather than a direct biological or physical injury risk.
Plain-English summary
Beckman Coulter Inc. is recalling three units of the UniCel DxH Slidemaker Stainer, Part Number 75222, which is used with automated hematology analyzers. The recall is due to a defect where the shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
The affected units are identified by serial numbers AW09034, AV40142, and AU19113. These units were distributed to locations in California, Arkansas, Hawaii, Ohio, Washington, Maryland, Canada, and Japan. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Users of these devices should contact Beckman Coulter Inc. for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 3
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 (3)
- Serial Numbers: AW09034
- AV40142
- AU19113
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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