FDA-Device2016-08-03Class II

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 Clin

Beckman Coulter Inc.
Hazard

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

Sold states
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.
Affected count
3,540 units total (1,067 units in US)
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2272-2016

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