Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

UniCel DxC 600i SYNCHRON Access Clinical Systems Recalled by Beckman Coulter Inc. Due to Potential for minor skin burn if the tool...

Date: November 6, 2017
Company: Beckman Coulter Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter Inc. directly.

Affected Products

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.

Quantity: 2 units

Why Was This Recalled?

Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.

Where Was This Sold?

Worldwide Distribution -- US, 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.

About Beckman Coulter Inc.

Beckman Coulter Inc. has 241 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report