Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit Recalled by Qualigen Inc Due to Specific lots have been reported to produce falsely...

Date: July 7, 2017
Company: Qualigen Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Qualigen Inc directly.

Affected Products

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

Quantity: 493 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Qualigen Inc

Qualigen Inc has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report