FDA-Device2024-09-11Class II
PE Centrifuge, REF: B36365, a component of the Power Express
Beckman Coulter Biomedical GmbH
Hazard
The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Bahrain, Canada, China, Colombia, Egypt, France, Germany, Italy, Jordan, Korea, Kuwait, Lebanon, Malaysia, Panama, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, United Arab Amirates, United Kingdom, Vietnam.
Manufactured in
Sauerbruchstr. 50, Munchen, Germany
Products
PE Centrifuge, REF: B36365, a component of the Power Express
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2979-2024Don't want to check this manually?
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