FastPack SHBG Immunoassay (Qualigen) – Incorrect Expiration Date (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Qualigen Inc
Lot Codes / Batch Numbers
UDI-DI: 20816467020345, Lot numbers: 2408018-1 Exp: 2025-09-05, 2409015-1, Exp: 2025-06-27, and 2409015-2, Exp: 2025-06-26.
Products Sold
UDI-DI: 20816467020345, Lot numbers: 2408018-1 Exp: 2025-09-05; 2409015-1, Exp: 2025-06-27; and 2409015-2, Exp: 2025-06-26.
Qualigen Inc is recalling The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative me due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The recalling firm issued letters dated 11/19/2024 via email to their customers explaining the reason for recall and providing the correct expiration dates for each of the affected lot numbers. The risk to health was provided and instructions given to be completed. The instructions were to cease use of the affected product, dispose of all remaining kits from the affected lot numbers, document the number of kits disposed, complete the acknowledgment form by FAX or email within 5 days.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, CA, CO, FL, IL, IN, MA, MO, NY, NC, OH, OK, TN, TX, VA
Page updated: Jan 10, 2026