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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
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