Drug recall
Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked…
FDA recall event 81550 · Class III · R & D Systems, Inc.
Key facts
| Event ID | 81550 |
|---|---|
| Recall numbers | Z-0691-2019 |
| Recalling firm | R & D Systems, Inc. |
| Product type | Devices |
| Products | Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4. |
| Initiation date | Nov 1, 2018 |
| Report date | Jan 9, 2019 |
| Termination date | Nov 3, 2020 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 2182501 |
At a glance
- 1–9 Products in this recall
- 1–9 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: