PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
Recall
- Recall Number
- Z-2980-2024
- Event Number
- 95064
- Firm
- Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munchen Germany
- FEI Number
- 3006677029
- Product Code
- CDD
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- July 17, 2024
- Posted
- September 5, 2024
Description
PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
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.
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.
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.