Quantikine IVD Human sTfR Immunoassay — Class II medical device recall Z-1255-2021

Terminated recall by R & D Systems, Inc., reported 2021-03-24, distributed in CA, FL, LA, OH. R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the sp

Recall number	`Z-1255-2021`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	R & D Systems, Inc., Minneapolis, MN, United States
Recall initiated	2021-01-20
Classified	2021-03-15
Reported by FDA	2021-03-24
Terminated	2023-02-13
Distributed	CA, FL, LA, OH
Countries outside the US	CN, GB, JP, SG
Quantity	156 kits
Reason classes	specification failure
UPC / GTIN / UDI-DI	`00815762021657`
Lot numbers	`P252478`, `P256349`, `P263156`, `P263160`, `P264604`
Model numbers	`DTFR1`

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1255-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.