Reported Sep 13, 2017 · Terminated

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

Qualigen Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Qualigen Inc · 2042 Corte Del Nogal · Carlsbad, CA · 92011-1438

Is this the product you have?

  • Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Lot codes and dates
  • Lot numbers
    • 1701033-3P
    • 1701033-4P
    • 1701033-5P
    • and 1701033-6P
Amount recalled
493 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 22, 2018 · Data as of Sep 19, 5:25 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.