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

Recall date

September 11, 2018

Source

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

Recall number

Z-0410-2019

FDA classification

Class III

Brand / firm

R & D Systems, Inc.

Sold / distributed

IA and CO

Why it was recalled

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.

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

What was recalled

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