Tosoh Bioscience recalls ST-AIA PACK FSH (Part 025265) due to potential false test results with reproductive hormone assays. Affected units may cause inaccurate immunoassay results.
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Tosoh Biosc: ST-AIA PACK FSH (Part 025265) is recalled because it can cause false high or low test results in reproductive hormone assays. This affects accuracy of certain lab tests and may lead to incorrect health decisions.
The ST-AIA PACK FSH assay can interfere with certain immunoassay tests for reproductive hormones, causing results to be too high or too low. This interference may lead to incorrect health assessments if the test is used without proper controls.
Lab users and healthcare professionals who perform reproductive hormone tests with this specific assay kit. Those using the kit for immunoassay testing are most at risk of inaccurate results.
Check for the product name 'ST-AIA PACK FSH' with Part Number 025265. All lot codes are affected. This kit is used in reproductive hormone testing.
Identify the product name and part number to confirm if it's affected.
The ST-AIA PACK FSH (Part 025265) can cause false high or low test results in reproductive hormone immunoassays, potentially leading to inaccurate health assessments.
The recall record does not specify a remedy, so check with your lab or healthcare provider for guidance.
The recall describes potential inaccurate test results, not physical injury risks. This is a low-risk issue for lab accuracy.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-2086-2018 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-2086-2018 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.
