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.
Reported: October 5, 2016 Initiated: August 24, 2016 #Z-2887-2016
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- R & D Systems, Inc.
- Units Affected
- 725 kits (502 US, 223 OUS)
- Distribution
- 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.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product 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.. Recalled by R & D Systems, Inc.. Units affected: 725 kits (502 US, 223 OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 5, 2016. Severity: Moderate. Recall number: Z-2887-2016.
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