Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determi
FDA device recall Z-0673-2025 · posted 2024-12-11 · Open, Classified
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- 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.
- Action taken
- 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 EDTA and/or lithium heparin plasma sample types if the tests are completed within the timeframes listed below upon sample presentation to the DxI 9000 Access Immunoassay Analyzer (see page 3 for instructions): o Access Intact PTH assay Routine Mode: 25 minutes. o Access Intact PTH assay Intraoperative Mode: 20 minutes. . Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to perform a retrospective review of the patient results generated from Access Intact PTH Routine Mode plasma samples on the DxI 9000 to determine if retesting is necessary.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- CEW
- Quantity affected
- 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, Kuwai
- Date initiated
- 2024-11-08
- Date posted
- 2024-12-11
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Access Intact PTH (K232791) | Beckman Coulter, Inc. | 2024-03-01 |