FDA Device recall Z-0691-2019
Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit
- FDA Device
- Class III
- terminated
- Published 2019-01-09
On 2019-01-09 the FDA classified a Class III recall of Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit by R And D Systems, citing the Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0691-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-11-01 |
| Published | 2019-01-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | R And D Systems |
| Distribution | US |
Product
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 plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.
Reason
The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
Identifiers
| code_info | Catalog number DTFR1, Lot number P180851 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0691-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.