FDAFDA · Food and drugs·Recall number Z-0410-2019
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Published November 14, 2018 · Recall initiated: September 11, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- R & D Systems, Inc.
- Distributor
- IA and CO
- Lot
- Manufacturing Lot # 182801
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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