Recall Z-0803-2025 ยท CEW Radioimmunoassay, Parathyroid Hormone
Beckman Coulter, Inc.
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972
| Date | Jan 3, 2025 (initiated Nov 26, 2024) |
| Status | Open, Classified |
| Reason | Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination, instrument errors, delays, or inaccurate results with a negative bias and increase in imprecision. The issue was confirmed on 10 April 2024 by Beckman Coulter through an internal non-conformance (NC-INT-66585). The well 0 scale on the filling line began malfunctioning on the fill immediately before PTH. The malfunction was not noticed until the majority of PTH was |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 11/26/24 was sent to customers. ACTION: Discontinue using Access Intact PTH reagent lot 339071 and discard all remaining reagent packs from this lot. 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 the affected Access Intact PTH reagent pack lot to determine if retesting is necessary. Beckman Coulter is investigating the root cause of this issue to prevent similar occurrences. Please |
| Quantity | 362 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061190 | ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 Beckman Coulter, Inc., Sep 15, 2006 |