Tosoh Bioscience recalls ST-AIA PACK hsE2 (Part 025225) due to potential false assay results in reproductive hormone tests. All lot codes affected.
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 its ST-AIA PACK hsE2 assay kit (Part Number 025225) because it can cause inaccurate test results when used with certain reproductive hormone tests. This means the kit might show higher or lower results than actual, which could affect medical decisions.
The ST-AIA PACK hsE2 kit can interfere with certain reproductive hormone assays, causing test results to be too high or too low. This interference might lead to incorrect medical conclusions if the test is used for diagnosis or monitoring.
Users of reproductive hormone tests who have the ST-AIA PACK hsE2 kit (Part Number 025225) are affected. People relying on accurate hormone test results for medical decisions are most at risk.
Check for the ST-AIA PACK hsE2 label with Part Number 025225. All lot codes of this kit are affected, so no specific lot numbers are safe.
Look for the Part Number 025225 on the ST-AIA PACK hsE2 kit to confirm it is affected.
No, only the ST-AIA PACK hsE2 kit (Part Number 025225) is affected. Other kits are not included.
The recall states the kit can cause inaccurate results, so it is not recommended for use. However, no specific action is required beyond checking the label.
The recall does not specify a remedy, so you can safely discard or stop using it if you are concerned about inaccurate 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-2089-2018 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-2089-2018 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.
