Tosoh Bioscience recalls ST-AIA HCG assay kits (Part 025256) due to potential false test results. All lot codes affected. Contact for remedy.
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 HCG assay kits (Part Number 025:256) because they can cause false test results when used with certain hormone tests. This means test results might be too high or too low, which could lead to incorrect health decisions.
The assay kit can interfere with certain hormone tests, causing results to be too high or too low. This might lead to incorrect health conclusions if the test is used for reproductive hormone levels.
People using these assay kits for reproductive hormone testing. Those who rely on accurate test results for health decisions are most at risk.
Check for the ST-AIA HCG assay kit with Part Number 025256. All lot codes are affected. This product is used in reproductive hormone testing.
Identify the product by checking the Part Number 025256 and all lot codes.
The ST-AIA HCG assay kit can cause false test results when used with certain hormone tests, potentially leading to incorrect health decisions.
The recall does not specify a remedy, so check with Tosoh Bioscience for further instructions.
No serious injury risk is mentioned in the recall. The hazard is limited to potential false test results.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-2084-2018 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-2084-2018 from Tosoh Bioscience. 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.
