Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay Recalled by Qualigen Inc Due to Qualigen initiated this recall because the FastPack kit...
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
FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer.
Quantity: 6
Why Was This Recalled?
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Where Was This Sold?
This product was distributed to 16 states: AL, CA, IN, KS, KY, MA, NV, NY, NC, OK, SC, TN, TX, UT, VA, WA
About Qualigen Inc
Qualigen Inc has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report