Lower riskMedical device recall · FDA · Published January 20, 2021
R&D Systems Quantikine sTfR ELISA Kit Recall: Low Signal and Control Issues
R&D Systems recalls Quantikine Human sTf:R ELISA Kit due to low signal and out-of-specification controls. Affected kits may not provide accurate anemia/polycythemia test results.
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.
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Contact the company
📍Recalling firmR & D Systems, Inc.614 Mckinley Pl Ne · Minneapolis, MN 55413-2610
✎ GovInfoNow plain-language explainer
R&D Systems is recalling Quantikine Human sTfR ELISA Kits because they produce low signal and out-of-specification controls, which could lead to inaccurate anemia or polycythemia test results. This affects kits with specific lot numbers and catalog codes. Read more at govinfonow.com/recall/63361-r-d-systems-quantikine-stfr-elisa-kit-recall-low-signal.
“R&D Systems Quantikine sTfR ELISA Kit Recall: Low Signal and Control Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63361-r-d-systems-quantikine-stfr-elisa-kit-recall-low-signal. Based on FDA recall #Z-1255-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1255-2021%22&limit=1).
The FDA announced on Jan. 20, 2021, that R & D Systems, Inc. is recalling Quantikine IVD Human sTfR Immunoassay kits due to low standard signals and out-of-specification controls. The agency issued recall number Z-1255-2021 for the voluntary Class II recall.
How to tell if you have it
Brand: R&D Systems
Product: Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit)
Catalog #: DTFR1
Lot codes: P252478, P263156, P256349, P263160, P264604
Units affected: 156 kits
The hazard
R&D Systems received two complaints that the standard signal was low and controls were not within the specification range. An investigation confirmed low standard signals and controls running out of specification for returned and retained kits.
Context
GovInfoNow's records show R & D Systems, Inc. has had four other recalls since Sept. 11, 2018, including a Nov. 7, 2022, recall for microbial contamination risk in CBC-3D Hematology Controls and a June 14, 2022, recall for CE marking errors. Other recent recalls of similar products include the Immunotech Estrone RIA Kit (Dec. 15, 2025), Stago STA Liatest Free Protein S (Feb. 4, 2026), and Roche Elecsys Anti-TSHR Assay (Nov. 21, 2025).
How to tell if you have this one
Check for the catalog number DTFR1 and lot numbers P252478, P263156, P256349, P263160, or P264604. The kit is sold as an enzyme-linked immunosorbent assay for human serum and plasma testing.
Brand
R&D Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Numbers
Verify if your kit has lot numbers P252478, P263156, P256349, P263160, or P264604.
Where it went and when
Where it was distributed
Distributed in 4 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “USA: (FL, LA, CA, OH), CHINA, UNITED KINGDOM, JAPAN, SINGAPORE, Jakarta Selatan,” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Louisiana, Ohio.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1255-2021 (January 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1255-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.