Beckman Coulter, Inc. Recall 95871
Description: 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
Beckman Coulter, Inc. Recall 95871 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0803-2025 |
| Event ID | 95871 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| Quantity | 362 units |
| Recall 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 filled. |
| Device Classification | 20250115 |
| Device Code Info | UDI: (01)15099590201937(17)241130(11)231201; Lot 339071 |
| Center Classification Date | 20250103 |
| Recall Initiation Date | 20241126 |
| Recalling Firm | Beckman Coulter, Inc. |
| Initial Notification | Letter |
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