Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Transferrin Receptor (sTfR) concentration in human serum and plasma as an aid in the diagnosis of anemia and polycythemia.

Reason: 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.

Code information: Catalog #: DTFR1; Unique Device Identification (UDI) #: 815762021657; Lot #: P252478; P263156; P256349; P263156; P263160; P264604

Distribution pattern: USA: (FL, LA, CA, OH), CHINA, UNITED KINGDOM, JAPAN, SINGAPORE, Jakarta Selatan,