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R & D Systems, Inc. recalls R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (s
Recalled October 5, 2016 · FDA recall Z-2887-2016 · R & D Systems
Hazard
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. · FDA Class II
Units
725 kits (502 US, 223 OUS)
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
R & D Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →