Lower riskMedical device recall · FDA · Published November 1, 2018
R&D Systems Quantikine sTfR ELISA Kit Recall: Incorrect Control Data Card
R&D Systems recalls Quantikine sTfR ELISA Kit (catalog DTFR1, lot P180851) due to incorrect control data card number. This may affect lab results accuracy for iron deficiency anemia testing.
“R&D Systems Quantikine sTfR ELISA Kit Recall: Incorrect Control Data Card.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69529-r-d-systems-quantikine-stfr-elisa-kit-recall-incorrect-control. Based on FDA recall #Z-0691-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0691-2019%22&limit=1).
The FDA announced on 2018-11-01 that R & D Systems, Inc. voluntarily recalled the Quantikine IVD ELISA, Human sTfR Immunoassay kit due to incorrect control data card numbers. The agency classified the recall as Class III.
How to tell if you have it
Brand: R&D Systems
Product: Quantikine IVD ELISA, Human sTfR Immunoassay kit
Catalog number: DTFR1
Lot number: P180851
Quantity: 198 kits
The hazard
The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180851 was packed with the incorrect control data card number 750228.4.
Context
GovInfoNow's records show R & D Systems, Inc. has 4 other recalls on record since 2018-09-11. Other recent recalls of similar products include Roche Elecsys Anti-TSHR Assay Recall (2025-11-21), Diagnostica Stago Asserachrom HPIA Kit Recall (2025-12-15), and Accriva Diagnostics recalls directCHECK ACT-LR blood control with incorrect labeling (2026-04-30).
How to tell if you have this one
Check for the catalog number DTFR1 and lot number P180851 on the kit packaging. The product is used for measuring sTfR in blood to help diagnose iron deficiency anemia.
Brand
R&D Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Packaging
Verify the catalog number DTFR1 and lot number P180851 on the kit's packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide and worldwide distribution to FL, LA, NE, MA. International distribution to Japan, Mexico, South Korea, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Louisiana, Massachusetts, Nebraska.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
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-0691-2019 (November 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0691-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.