# FDA recall Z-0410-2019

> **R & D Systems, Inc.** · Class III · device recall initiated 2018-09-11.

## 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.

## Distribution

IA and CO

## Key facts

- **Recall number:** Z-0410-2019
- **Recalling firm:** R & D Systems, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-11
- **Report date:** 2018-11-14
- **Termination date:** 2020-09-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0410-2019

## Citation

> AI Analytics. FDA recall Z-0410-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0410-2019. Source: US FDA. Licensed CC0.

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