Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
The FastPack IP Sex Hormone Binding Globulin Immunoassay Recalled by Qualigen Inc Due to Three lots of the FastPacks kitted into the...
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
The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.
Quantity: 426
Why Was This Recalled?
Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due to age.
Where Was This Sold?
This product was distributed to 15 states: AR, CA, CO, FL, IL, IN, MA, MO, NY, NC, OH, OK, TN, TX, VA
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