Qualigen recalls three lots of FastPack SHBG kits with incorrect expiration dates. The risk of patient harm is low as routine quality control should detect affected kits.
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.
Qualigen is recalling three specific lots of FastPack SHBG kits that have incorrect expiration dates. This could lead to potential issues with test accuracy, but the risk of harm is considered low because routine quality checks usually catch kits that degrade over time.
The kits have incorrect expiration dates, which could lead to inaccurate test results if used after the intended expiration. However, routine quality control processes typically detect kits that have deteriorated due to age, so the risk of serious harm is low.
Patients using these kits for hormone testing may be affected. Those who have recently purchased the kits with the listed lot numbers are most at risk.
Check the lot number on the kit packaging. Affected lots are 2408018-1, 2409015-1, and 2409015-2. These kits were sold with expiration dates that do not match the actual expiration dates.
Verify the lot number on the kit packaging to see if it matches the affected lots listed: 2408018-1, 2409015-1, or 2409015-2.
The recall is due to incorrect expiration dates on three specific lots of FastPack SHBG kits, which could lead to inaccurate test results if used after the intended expiration.
The risk of serious harm is low because routine quality control should detect kits that have deteriorated due to age, so the likelihood of patient harm is expected to be low.
Check the lot number on the kit packaging. If it matches the affected lots (2408018-1, 2409015-1, or 2409015-2), you may want to contact Qualigen for further instructions.
We’ve drafted a message you can send Qualigen to request your refund or repair — edit it as you like.
Subject: Recall Z-0805-2025 — Qualigen Qualigen Hello, I own a Qualigen that is covered by recall Z-0805-2025 from Qualigen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
