FDA-Device2018-11-14Class III
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
R & D Systems, Inc.
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.
Sold states
IA and CO
Affected count
8 kits
Manufactured in
614 McKinley Pl NE, Minneapolis, MN, United States
Products
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0410-2019Don't want to check this manually?
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