Reported Oct 5, 2016 · Terminated

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

R & D Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: R & D Systems, Inc. · 614 McKinley Pl NE · Minneapolis, MN · 55413-2610

Is this the product you have?

  • 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.
Lot codes and dates
    • 331636
    • 331637
    • 332060
    • 332090
    • 332924
    • 334184
    • 335062
    • 335740
    • 336694
    • 339307
    • 340362
Amount recalled
725 kits (502 US, 223 OUS)

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 26, 2017 · Data as of Sep 19, 6:00 PM UTC

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