R & D Systems, Inc. recalls Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorb…

Recall date

November 1, 2018

Source

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

Recall number

Z-0691-2019

FDA classification

Class III

Brand / firm

R & D Systems, Inc.

Sold / distributed

US Nationwide and worldwide distribution to FL, LA, NE, MA. International distribution to Japan, Mexico, South Korea, United Kingdom.

Why it was recalled

The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.