Beckman Coulter Biomedical GmbH: Device Recall

Recall #Z-2980-2024 · 07/17/2024

Class II: Risk

Recall Details

Recall Number
Z-2980-2024
Classification
Class II
Product Type
Device
Recalling Firm
Beckman Coulter Biomedical GmbH
Status
Ongoing
Date Initiated
07/17/2024
Location
Munchen, Germany
Voluntary/Mandated
Voluntary: Firm initiated

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.

Product Description

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

Distribution Pattern

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.