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FDASeptember 11, 2018device

R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL.

What to do

FDA enforcement status: Terminated

Brands named

r d systems

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971 — Recall Details · AllClear