Tosoh Bioscience recalls ST-AIA SHBG assay kits (part 025238) due to potential false test results. Affected units may cause inaccurate reproductive hormone measurements.
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Tosoh Bioscience is recalling ST-AIA SHBG assay kits (part number 025238) because they can cause false high or low results in reproductive hormone tests. This means test results might be inaccurate, which could affect medical decisions.
The assay kits can produce false high or low results when used with Asfotase Alfa (Strensiq) medication. This happens because the medication interferes with the test's chemical process, leading to inaccurate measurements.
People using these assay kits for reproductive hormone testing. Those with medical conditions requiring precise hormone monitoring are most at risk.
Check for the product name 'ST-AIA PACK SHBG' with part number 025238. All lot codes are affected. The product is used in reproductive hormone testing.
Identify if your kit has the part number 025238 and is labeled for reproductive hormone testing.
No, but you should check if your kit is affected before using it with Asfotase Alfa (Strensiq).
Inaccurate results could lead to incorrect medical decisions, so you should consult your healthcare provider.
The recall does not provide a fix; you need to check if your kit is affected and avoid using it with Asfotase Alfa.
We’ve drafted a message you can send Tosoh Biosc: Inc to request your refund or repair — edit it as you like.
Subject: Recall Z-2092-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc Hello, I own a Tosoh Biosc: Inc that is covered by recall Z-2092-2018 from Tosoh Biosc: Inc. 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.
