Beckman Coulter Recalls No Foam DxC Reagent Due to Incompatibility
Beckman Coulter is recalling No Foam DxC reagent because it is incompatible with DxC hydropneumatic parts, potentially affecting UniCel DxC System analyzers.
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 functional incompatibility without reporting any specific injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or functional defects without reported harm.
Plain-English summary
Beckman Coulter Inc. is recalling the Synchron Systems No Foam DxC reagent (Reference No. B64130). The recall affects all lots of the reagent, which is used with the UniCel DxC System chemistry analyzer.
The recall was initiated because Beckman Coulter identified an incompatibility between the No Foam DxC reagent and the DxC hydropneumatic parts associated with No Foam delivery. This incompatibility may affect the performance of the chemistry analyzer.
A total of 4,221 units were distributed, with 2,033 units in the United States. The product was distributed to various countries, including the United States, Canada, and numerous international locations. Users of the UniCel DxC System should contact Beckman Coulter for further instructions on how to proceed.
The recalled product
- Product
- The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall.
- 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)
- All
Distribution
Distributed in 1 state:
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