Class III — R & D Systems, Inc.
| Recalling firm | R & D SYSTEMS, INC. |
|---|---|
| Registered facility | R & D SYSTEMS, INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | 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. |
| Product | R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971 |
| Quantity | 8 kits |
| Distribution | IA and CO |
| Initiated | 2018-09-11 |
| Classified | 2018-11-08 |
| Terminated | 2020-09-01 |
| Recall number | Z-0410-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — R & D Systems, Inc. (Z-0410-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81121/
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