# FDA recall Z-3112-2017

> **Qualigen Inc** · Class II · device recall initiated 2017-07-07.

## Product

Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068    Vitamin D immunoassay kit

## Reason for recall

Specific lots have been reported to produce falsely lower than expected results for Vitamin D

## Distribution

Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE.

## Key facts

- **Recall number:** Z-3112-2017
- **Recalling firm:** Qualigen Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-07
- **Report date:** 2017-09-13
- **Termination date:** 2018-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3112-2017

## Citation

> AI Analytics. FDA recall Z-3112-2017. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-3112-2017. Source: US FDA. Licensed CC0.

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