Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Recalled by Beckman Coulter Inc. Due to Possible leaking of No Foam solution from the...

Date: April 22, 2014
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 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 Hydro System. Catalog No. UniCel DxC 800 Synchron Clinical Systems UniCel DxC 600 Synchron Clinical Systems UniCel DxC 600i Synchron Access Integrated Clinical Systems UniCel DxC 880i Synchron Access Integrated Clinical Systems UniCel DxC 660i Synchron Access Integrated Clinical Systems Product Labeling Reference No. A93719 For the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.

Quantity: 3,540 units total (1,067 units in US)

Why Was This Recalled?

Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems.

Where Was This Sold?

Worldwide Distribution -- United Arab Emirates, Angola, Australia, Belgium, Bulgaria, Canada, Switzerland, China, Colombia, Costa Rica , Czech Republic, Germany, Denmark, Egypt, Eritrea, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Ireland, India, Italy, Jordan, Japan, Korea, Republic of, Kuwait, Lebanon, Lithuania, Morocco, Mexico, Malaysia, Namibia, Netherlands, Norway, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Serbia, Russian Federation, Rwanda, Saudi Arabia, Sweden, Singapore, Slovakia, Swaziland, Thailand, Tunisia, Turkey, Taiwan, US (including Puerto Rico), Vietnam, South Africa, and Zimbabwe.

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