Beckman Coulter Recalls UniCel Dxl 800 Access Immunoassay Systems
Beckman Coulter is recalling 1,756 UniCel Dxl 800 Access Immunoassay Systems due to confirmed field modifications to probe assemblies.
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 illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Beckman Coulter Inc. is recalling 1,756 units of the UniCel Dxl 800 Access Immunoassay System, including part numbers 973100, A71456, and A71457. The affected devices have serial numbers ranging from 600000 through 602389. These in vitro diagnostic devices are used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations in human body fluids.
The recall was initiated because Beckman Coulter confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies. The recall is classified as Class II by the U.S. Food and Drug Administration.
The affected units were distributed nationwide in the United States and internationally to numerous countries, including Canada, Australia, Germany, France, and the United Kingdom. Users of these devices should contact Beckman Coulter for further instructions regarding the field modifications.
The recalled product
- Product
- UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 1,756
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 Numbers: 600000 through 602389
Distribution
Distributed nationwide across the United States.
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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