The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-0310-2018·Announced 2018-01-10

Beckman Coulter Recalls UniCel DxC 600i Systems Due to Burn Risk

Beckman Coulter is recalling two UniCel DxC 600i SYNCHRON Access Clinical Systems because a tool may contact a board and cause minor skin burns during alignment.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, and the source text explicitly describes the hazard as a 'minor skin burn,' which aligns with the rubric for cosmetic defects or low-risk issues unlikely to cause adverse health consequences.

Plain-English summary

Beckman Coulter Inc. is recalling two units of the UniCel DxC 600i SYNCHRON Access Clinical Systems, identified by serial/lot numbers 801060 and 801061. These in vitro diagnostic devices are used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

The recall is due to a potential for minor skin burns if a tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment. The affected units were distributed worldwide, including in the United States, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey, United Kingdom, and Vietnam.

Healthcare facilities and users should contact Beckman Coulter Inc. for instructions on how to proceed with the recall. The U.S. Food and Drug Administration has classified this recall as Class III, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product
UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
2

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/Lot Numbers: 801060 and 801061

Distribution

Distributed in 1 state:

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.

See all 3 products in this recall →

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