Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR Recalled by R & D Systems, Inc. Due to R&D Systems, Inc. received two complaints that the...

Date: January 20, 2021
Company: R & D Systems, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact R & D Systems, Inc. directly.

Affected Products

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.

Quantity: 156 kits

Why Was This 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.

Where Was This Sold?

This product was distributed to 4 states: CA, FL, LA, OH

Affected (4 states)Not affected

About R & D Systems, Inc.

R & D Systems, Inc. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report