Recall Z-2980-2024 ยท CDD Radioassay, Vitamin B12
Beckman Coulter Biomedical GmbH
PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
| Date | Sep 5, 2024 (initiated Jul 17, 2024) |
| Status | Open, Classified |
| 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 thi |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140496 | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sa Beckman Coulter, Inc., Sep 16, 2014 |