Immunochemical, Transferrin
Immunology · 21 CFR 866.5880
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- R & D Systems, Inc.TerminatedSep 26, 2016
R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and pla
R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine IVD Human sTfR Immunoassay kit were out of the range high. Internal testing within R&D Systems confirmed a problem with Control results being out of range high.
Z-2887-2016 · View FDA record ↗ - R & D Systems, Inc.TerminatedUnknown
Quantikine IVD ELISA, Human sTfR Immunoassay kit.
The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
Z-0691-2019 · View FDA record ↗ - R & D Systems, Inc.TerminatedUnknown
Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the qua
R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard signal and controls running out of specification for kits returned from the customer and the retained kits.
Z-1255-2021 · View FDA record ↗
Registered firms
3 firms currently registered for this product code
510(k) clearances
3 clearances for this product code