Class II — Potential Health Hazard

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

R&D Systems Recalled by R & D Systems, Inc. Due to R&D Systems, Inc. received two customer complaints that...

Date: August 24, 2016
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

R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1.

Quantity: 725 kits (502 US, 223 OUS)

Why Was This Recalled?

R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine¿ IVD¿ Human sTfR Immunoassay kit were out of the range high. Internal testing within R&D Systems confirmed a problem with Control results being out of range high.

Where Was This Sold?

This product was distributed to 12 states: CA, CO, KY, LA, MD, MA, NJ, OH, RI, UT, VA, WA

Affected (12 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