FDA Medical Device Recalls (openFDA)
Beckman Coulter Biomedical GmbH: PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
- Recall number
- Z-2980-2024
- Recalling firm
- Beckman Coulter Biomedical GmbH
- Product
- PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
- Status
- Open, Classified
- Initiated
- 2024-07-17
- Posted
- 2024-09-05
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- On July 18, 2024, Beckman Coulter issued a "Urgent Medical Device Recall" notification to affected consignees. Beckman Coulter asked consignees to take the following actions: 1. follow your laboratory procedure to handle biohazard materials and contact your Beckman Coulter representative for servicing your Power Express system. 2. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected products listed above to another laboratory, please provide them a copy of this letter. 3. respond within 10 days in one of the following ways: . Electronically, if you received this communication via email. . Manually, complete and return the enclosed Response Form. 4. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- UDI: (01)15099590673567/ All serial numbers
- 510(k) numbers
- ["K140496"]
- PMA numbers
- not on file
- Product code
- CDD
- Firm FEI
- 3006677029
- Firm city
- Munchen
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28