Beckman Coulter UniCel DxH600 Hematology Analyzer Recall for Sample Aspiration Issue
Beckman Coulter is recalling the UniCel DxH600 automated hematology analyzer because a 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 does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving a potential functional defect.
Plain-English summary
Beckman Coulter Inc. is recalling the UniCel DxH600 automated hematology analyzer, Part Number B23858. The recall involves 1 unit with Serial Number AZ06682. The product is a benchtop unit that is identical to the DxH 800 except for the absence of an instrument cart, computer stand, and connectivity capabilities.
The recall is being issued because the shield for the Single-Tube Station on the instrument may interfere with sample aspiration in the open vial position. This defect could potentially affect the accuracy of the hematology analysis performed by the device.
The affected unit was distributed to locations in California, Arkansas, Hawaii, Ohio, Washington, Maryland, Canada, and Japan. Users of this specific device should contact Beckman Coulter Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 1
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 (1)
- Serial Number AZ06682
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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