Z-2980-2024 Class II Ongoing
FDA device recall Z-2980-2024 was initiated by Beckman Coulter Biomedical GmbH on Jul 17, 2024 and is designated Class II. 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… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 11, 2024
- Initiation Date
- Jul 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
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 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.
Code Information
UDI: (01)15099590673567/ All serial numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2980-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026