Qualigen FastPack Vitamin D Kit: False Low Results Risk
Qualigen recalls specific Vitamin D test kits that may give falsely low results. Affected lots: 1701033-3P to 1701033-6P. No remedy stated in official notice.
Lower-risk recall
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
Contact the company
What happened, in plain English
Qualigen is recalling certain Vitamin D test kits that might show falsely low results. This could lead to incorrect health decisions if used for testing. The recall covers specific lot numbers. Read more at govinfonow.com/recall/73454-qualigen-fastpack-vitamin-d-kit-false-low-results-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73454-qualigen-fastpack-vitamin-d-kit-false-low-results-risk · Updated September 21, 2026 · FDA enforcement record: FDA #Z-3112-2017
Cite this page
“Qualigen FastPack Vitamin D Kit: False Low Results Risk.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73454-qualigen-fastpack-vitamin-d-kit-false-low-results-risk. Based on FDA recall #Z-3112-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3112-2017%22&limit=1).
Why it’s dangerous
The test kits may produce results that are lower than expected for Vitamin D levels. This could lead to incorrect health conclusions if the test is used for medical purposes. The issue is specific to certain lots.
Who’s affected
People who bought the Qualigen FastPack Vitamin D test kit with lot numbers 1701033-3P through 1701033-6P. Those using the kit for medical testing may be at risk of inaccurate results.
How to tell if you have this one
Check the lot number on the kit label. Affected lots are 1701033-3P, 1701033-4P, 1701033-5P, and 1701033-6P. The product is a Vitamin D immunoassay kit from Qualigen Inc.
- Brand
Qualigen- Category
Medical device
What to do — step by step
Check Lot Number
Look for the lot number on the kit label to see if it matches 1701033-3P, 1701033-4P, 1701033-5P, or 1701033-6P.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3112-2017 (July 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3112-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.