Recall Z-0673-2025 · CEW Radioimmunoassay, Parathyroid Hormone
Beckman Coulter Inc.
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.
| Date | Dec 11, 2024 (initiated Nov 8, 2024) |
| Status | Open, Classified |
| Reason | The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid hormone) test may produce falsely decreased intact parathyroid hormone results. This could lead to a missed diagnosis, a delay in treatment, or inappropriate clinical management, depending upon the patient s clinical condition. |
| Root cause | Process design |
| Action | On November 8, 2024, the firm notified affected customers via URGENT MEDICAL DEVICE RECALL letters that the affected assay may produce falsely decreased results if EDTA and lithium heparin plasma samples are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the test. Access Intact PTH assay Routine Mode and Intraoperative Mode users can select any of the following options: . Use serum as the sample type. . Perform testing on an alternate methodology, such as the Access 2 or UniCel DxI 600 or 800 Immunoassay Analyzers. . Continue to use ED |
| Quantity | 31 US; 167 OUS |
| Distribution | Foreign distribution to Albania, Australia, Austria, Bahrain, Belgium, Brazil, C¿te d'Ivoire, Croatia, Czechia, Egypt, France, Germany, Ghana, Hungary, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Malaysia, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, S. Korea, Spain, Sw |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232791 | Access Intact PTH Beckman Coulter, Inc., Mar 1, 2024 |