R&D Systems Recalls Vitamin D ELISA Kits Due to Labeling Error
R&D Systems is recalling eight Human Total 25-OH Vitamin D IVD ELISA Kits because they were shipped without lot-specific booklets and contained a calibrator vial with an incorrect reconstitution volume label.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issues are documentation and labeling errors.
Plain-English summary
R&D Systems, Inc. is recalling eight units of the Human Total 25-OH Vitamin D IVD ELISA Kit, reference number RDKAP1971. The affected units are from manufacturing lot # 182801. The recall was initiated because the kits were provided without a copy of the lot-specific kit booklet. Additionally, the Calibrator 0 vial (18D1/4) label incorrectly specified a reconstitution volume of 2mL.
The affected products were distributed in Iowa (IA) and Colorado (CO). The recall is classified as Class III by the U.S. Food and Drug Administration, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and facilities that have received these specific kits should stop using them and contact R&D Systems, Inc. for further instructions or a return.
The recalled product
- Product
- R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
- Manufacturer
- R & D Systems, Inc.
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Manufacturing Lot # 182801
Distribution
Related recalls
Same manufacturer · R & D Systems, Inc.
See all →- ModerateR&D CBC-3D Hematology Control Recalled for Potential Microbial Contamination
FDA (Devices) · 2023-01-25
- LowErythropoietin Control Product Instructions Contain Incorrect CE Marking
FDA (Devices) · 2022-07-27
- ModerateR&D Systems Recalls Quantikine IVD Human sTfR Immunoassay Kits
FDA (Devices) · 2021-03-24
- LowR&D Systems Recalls Human sTfR ELISA Kits Due to Incorrect Control Card
FDA (Devices) · 2019-01-09
- ModerateR&D Systems Recalls Quantikine IVD sTfR Immunoassay Kits Due to Control Issues
FDA (Devices) · 2016-10-05
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02