R & D Systems, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
R & D Systems, Inc.
Lot Codes / Batch Numbers
Catalog #: DTFR1, Unique Device Identification (UDI) #: 815762021657, Lot #: P252478, P263156, P256349, P263156, P263160, P264604
Products Sold
Catalog #: DTFR1; Unique Device Identification (UDI) #: 815762021657; Lot #: P252478; P263156; P256349; P263156; P263160; P264604
R & D Systems, Inc. is recalling Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system) due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Users of these kits are requested to stop using these kits for measuring Human sTfR for diagnostic purposes in patient samples and to discard all unused kits or kit components. Customers were instructed to complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form to R&D Systems by February 20, 2021, by emailing the form to techserv@bio-techne.com. For questions regarding this recall, or need to obtain a product credit, contact Bio-Technes Technical Service Department at 1-612-379-2956 or techserv@bio-techne.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, LA, OH
Page updated: Jan 10, 2026