Class III — R & D Systems, Inc.
| Recalling firm | R & D SYSTEMS, INC. |
|---|---|
| Registered facility | R & D SYSTEMS, INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4. |
| 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. |
| Quantity | 198 kits |
| Distribution | US Nationwide and worldwide distribution to FL, LA, NE, MA. International distribution to Japan, Mexico, South Korea, United Kingdom. |
| Initiated | 2018-11-01 |
| Classified | 2019-01-03 |
| Terminated | 2020-11-03 |
| Recall number | Z-0691-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — R & D Systems, Inc. (Z-0691-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81550/
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