Reported Nov 14, 2018 · Terminated
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
R & D Systems, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
- Lot codes and dates
- Manufacturing Lot # 182801
- Amount recalled
- 8 kits
Where it was sold
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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