Tosoh Biosc: ST-AIA PACK LH II (Part 025296) may cause false test results in reproductive hormone assays. Affected units: all lot codes. No remedy specified in recall.
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 LH II reproductive hormone assay kit (Part Number 025296) because it can cause false test results when used with certain Asfotase Alfa (Strensiq) treatments. This could lead to incorrect medical decisions if the test results are relied upon.
The assay kit can produce false high or low results when used with Asfotase Alfa (Strensiq) treatments. This could lead to incorrect medical decisions if the test results are used without proper verification.
People using the ST-AIA PACK LH II assay kit with Asfotase Alfa (Strensiq) treatments may be affected. Those who rely on the test results for medical decisions are most at risk.
Check for the ST-AIA PACK LH II assay kit with Part Number 025296. All lot codes are affected. This product is sold for reproductive hormone testing.
Identify if you have the ST-AIA PACK LH II assay kit with Part Number 025296. All lot codes are affected.
The recall record does not specify a remedy.
The recall record does not specify a remedy.
The recall record does not mention any risk of serious injury.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-2090-2018 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-2090-2018 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.
