Z-1255-2021Class II

Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An...

Name: Z-1255-2021 Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An...
Creator: R & D Systems, Inc.
Published: 2021-01-20
License: https://open.fda.gov/license/

R & D Systems, Inc. / initiated 2021-01-20 / Terminated

FDA source

R & D Systems, Inc. began a recall of Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the... on 2021-01-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1255-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-20
Posted: 2021-03-15
Terminated: 2023-02-13
Recalling firm: R & D Systems, Inc.
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.
Product code: JNM Immunochemical, Transferrin
Reason for recall: 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: Under Investigation by firm
Action: 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].
Quantity in commerce: 156 kits
Distribution: USA: (FL, LA, CA, OH), CHINA, UNITED KINGDOM, JAPAN, SINGAPORE, Jakarta Selatan,
Product codes and lots: Catalog #: DTFR1; Unique Device Identification (UDI) #: 815762021657; Lot #: P252478; P263156; P256349; P263156; P263160; P264604

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1255-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1255-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-15

Product code JNM

K970718Class IIQuantikine IVD Stfr Enzyme Linked Immunosorbent Assay (Elisa)R&D Systems, Inc. / cleared 1997-05-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)