Quantikine¿ IVD¿ ELISA — Class III medical device recall Z-0691-2019
Terminated recall by R & D Systems, Inc., reported 2019-01-09, distributed nationwide. The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control da
| Recall number | Z-0691-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | R & D Systems, Inc., Minneapolis, MN, United States |
| Recall initiated | 2018-11-01 |
| Classified | 2019-01-03 |
| Reported by FDA | 2019-01-09 |
| Terminated | 2020-11-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB, JP, KR, MX |
| Quantity | 198 kits |
| Lot numbers | P180851 |
| Model numbers | DTFR1 |
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 for recall
The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0691-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.