Beckman Coulter Recalls UniCel DxH Analysis Systems for Optical Defect
Beckman Coulter is recalling UniCel DxH800 and DxH600 systems because optical degradation may delay reporting of specific blood test results.
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 hazard is a potential delay in reporting results rather than a direct physical injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems. The recall is due to optical degradation that may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential, and reticulocyte.
The affected units are distributed worldwide, including in the United States, Canada, and numerous other countries. The source text does not specify the total number of units affected or the specific lot numbers involved in this recall.
Healthcare facilities and users of these systems should contact Beckman Coulter for instructions on how to proceed with the recall and to ensure accurate reporting of blood test results.
The recalled product
- Product
- Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
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)
- Lot No. 3040200 3056140 3071360
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 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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