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
- Recall Number
- Z-1255-2021
- Event Number
- 87223
- Firm
- R & D Systems, Inc.
- FEI Number
- 2182501
- Product Code
- JNM
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- January 20, 2021
- Terminated
- February 13, 2023
- Address
- 614 Mckinley Pl Ne, Minneapolis, MN, 55413-2610
Description
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.
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.
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 [email protected]. For questions regarding this recall, or need to obtain a product credit, contact Bio-Technes Technical Service Department at 1-612-379-2956 or [email protected].
USA: (FL, LA, CA, OH), CHINA, UNITED KINGDOM, JAPAN, SINGAPORE, Jakarta Selatan,
156 kits