CLASS II Device recall · Reported 13 Sep 2017 · FDA Enforcement Report

Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit recalled

Qualigen is recalling Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, distributed nationwide in the US. The recall was initiated on 7 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers: 1701033-3P, 1701033-4P, 1701033-5P, and 1701033-6P

Quantity recalled493 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3112-2017
FDA event ID: 77726
Recalling firm: Qualigen, Carlsbad, CA
Classification: Class II
Status: Terminated
Recall initiated: 7 Jul 2017
FDA classified: 7 Sep 2017
Reported: 13 Sep 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

7 Jul 2017	Recall initiated by company
7 Sep 2017	Classified by FDA	+62 days
13 Sep 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot numbers: 1701033-3P, 1701033-4P, 1701033-5P, and 1701033-6P

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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