R & D Systems, Inc. recalls R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (…

Recall date

August 24, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2887-2016

FDA classification

Class II

Brand / firm

R & D Systems, Inc.

Sold / distributed

US: CA, CO, KY, LA, MD, MA, NJ, OH, RI, UT, VA, WA. OUS: AUSTRALIA, China, INDIA, INDONESIA, ISRAEL, JAPAN, MEXICO, SOUTH KOREA, UNITED KINGDOM.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.