Beckman Coulter Recalls UniCel DxC Immunoassay Systems Due to Field Modifications
Beckman Coulter is recalling UniCel DxC and Dxl Immunoassay Systems because field modifications were made to the aspirate and dispense 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with confirmed field modifications to critical components (probes), representing a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Beckman Coulter Inc. is recalling UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, as well as UniCel Dxl Immunoassay Systems. The affected products are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
The recall was initiated because Beckman Coulter confirmed that field modifications had been made to the aspirate and dispense probe assemblies of these systems. The affected units were distributed worldwide, including nationwide in the United States and internationally to numerous countries.
No specific illnesses or injuries are reported in the source text. Users of these devices should contact Beckman Coulter for further instructions regarding the field modifications.
The recalled product
- Product
- UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte…
- Manufacturer
- Beckman Coulter Inc.
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: Included in the corresponding Dxl system.
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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