Drug recall
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative…
FDA recall event 95871 · Class II · Beckman Coulter, Inc.
Key facts
| Event ID | 95871 |
|---|---|
| Recall numbers | Z-0803-2025 |
| Recalling firm | Beckman Coulter, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Nov 26, 2024 |
| Report date | Jan 15, 2025 |
| City | Chaska |
| State | MN |
| Country | United States |
| FEI number | 2122870 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: