FDA Device recall Z-0410-2019
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
- FDA Device
- Class III
- terminated
- Published 2018-11-14
On 2018-11-14 the FDA classified a Class III recall of R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971 by R And D Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0410-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-09-11 |
| Published | 2018-11-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | R And D Systems |
| Distribution | CO, IA |
Product
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
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.
Identifiers
| code_info | Manufacturing Lot # 182801 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0410-2019%22
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