Beckman Coulter Inc.: Medical Device Recall in 2016 - (Recall #: Z-2272-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 22, 2014

Date Posted: August 3, 2016

Recall Number: Z-2272-2016

Event ID: 74569

Reason for Recall:

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

Status: Terminated

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

Code Information:

Up to and including 6133

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated