R&D systems — Class III medical device recall Z-0410-2019
Terminated recall by R & D Systems, Inc., reported 2018-11-14, distributed in CO, IA. The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label inc
| Recall number | Z-0410-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | R & D Systems, Inc., Minneapolis, MN, United States |
| Recall initiated | 2018-09-11 |
| Classified | 2018-11-08 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2020-09-01 |
| Distributed | CO, IA |
| Quantity | 8 kits |
| Reason classes | labeling |
| Lot numbers | 182801 |
| Model numbers | RDKAP1971 |
Product
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0410-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.