Qualigen recalls FastPack SHBG immunoassay kits due to potential inaccurate hormone binding globulin measurements. This may affect medical testing for hormone disorders.
The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma.
Qualigen is recalling its FastPack SHBG immunoassay kits because they can produce inaccurate hormone binding globulin measurements. This could lead to incorrect medical diagnoses for hormone-related conditions.
The chemiluminescent immunoassay in these kits produces higher than expected results, which may cause inaccurate quantitative measurements of Sex Hormone Binding Globulin (SHBG). This could lead to incorrect medical diagnoses for hormone disorders.
Healthcare providers using these kits for hormone testing may be affected. Patients relying on these tests for androgen disorder diagnosis could see inaccurate results.
The FastPack SHBG immunoassay kits with reference number 25000081 (IVD CE) were sold starting from 2020-02-22. These kits are used for hormone testing in medical labs.
Look for the reference number 25000081 on the kit packaging.
The kit may produce higher than expected results, leading to inaccurate measurements of Sex Hormone Binding Globulin (SHBG).
Inaccurate results could lead to incorrect medical diagnoses for hormone disorders, but the risk is not severe enough to require immediate stoppage.
The kit has reference number 25000081 (IVD CE) and was sold starting February 22, 2020.
We’ve drafted a message you can send Qualigen to request your refund or repair — edit it as you like.
Subject: Recall Z-1672-2020 — Qualigen Qualigen Hello, I own a Qualigen that is covered by recall Z-1672-2020 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.
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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.
