Medical Device Recall: PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
Beckman Coulter Biomedical GmbH · July 17, 2024
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2980-2024
Status: ongoing
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