FDA Device recall Z-0673-2025
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact pa…
- FDA Device
- Class II
- ongoing
- Published 2024-12-18
On 2024-12-18 the FDA classified a Class II recall of Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact pa… by Beckman Coulter, citing 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 pe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0673-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-08 |
| Published | 2024-12-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | n/a |
Product
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.
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.
Identifiers
| code_info | UDI-DI 15099590201937 Lots 338921 339071 372223 439138 439205 439206 439207 439650 439801 439889 440026 440090 472012 472092 472136 472154 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0673-2025%22
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