# FDA recall Z-2390-2018

> **Roche Diagnostics Corporation** · Class II · device recall initiated 2018-04-27.

## Product

Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160    Product Usage:  This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the immunoassay analyzer.

## Reason for recall

The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2390-2018
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-27
- **Report date:** 2018-07-18
- **Termination date:** 2020-05-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2390-2018

## Citation

> AI Analytics. FDA recall Z-2390-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2390-2018. Source: US FDA. Licensed CC0.

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