Beckman Coulter Recalls UniCel DxC Synchron Systems Due to Leaking Solution
Beckman Coulter is recalling UniCel DxC Synchron Clinical Systems because the No Foam Bottle Assembly may leak solution.
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, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems. The recall involves Part number 70300, specifically Part number 970300, which is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hydro System.
The recall is being conducted because of a possible leak of No Foam solution from the No Foam Bottle Assembly. The affected systems are used for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
A total of 3,540 units were distributed worldwide, with 1,067 units distributed in the United States. The affected units have lot codes up to and including 6133. The recall covers multiple countries, including the United States (including Puerto Rico), Canada, and various nations in Europe, Asia, Africa, and the Middle East.
The recalled product
- Product
- UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC…
- 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)
- Up to and including 6133
Distribution
Distributed in 1 state:
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