Beckman Coulter Biomedical GmbH recalls PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.

Recall date

July 17, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2980-2024

FDA classification

Class II

Brand / firm

Beckman Coulter Biomedical GmbH

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.