Quantikine IVD Human sTfR Immunoassay (Human sTransferrin… recallZ-1255-2021 · R & D Systems, Inc. · initiated Jan 20, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from R & D Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-1255-2021
- Status
- Terminated
- Initiated by the company
- Jan 20, 2021
- Recalling firm
- R & D Systems, Inc.
- Quantity
- 156 kits
- Product code
- JNM
- FDA submissions
- K970718
- Distribution
- USA: (FL, LA, CA, OH), CHINA, UNITED KINGDOM, JAPAN, SINGAPORE, Jakarta Selatan,
Product 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.
Code information (models, lots, serial numbers)
Catalog #: DTFR1; Unique Device Identification (UDI) #: 815762021657; Lot #: P252478; P263156; P256349; P263156; P263160; P264604
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Research and Diagnostic Systems DTFR1Research And Diagnostic Systems, Inc. · Immunochemical, Transferrin1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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