Tosoh recalls ST-AIA Pack BMG (Part 025259) for potential false assay results in tumor marker tests. Affected units may cause inaccurate test 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 Bioscience recalls a specific tumor marker assay kit that could produce false high or low results when used with certain tests. This affects lab testing accuracy and could lead to incorrect health conclusions.
The assay kit contains Asfotase Alfa (Strensiq) which can interfere with certain tumor marker tests. This interference may cause test results to be too high or too low, leading to inaccurate health assessments.
Lab technicians and healthcare providers using the ST-AIA Pack BMG assay kit for tumor marker testing. Those most at risk are users who rely on accurate test results for patient diagnosis.
Check for the ST-AIA Pack BMG assay kit with Part Number 025259. All lot codes are affected. This product is used in lab settings for tumor marker testing.
Identify the product by checking the Part Number 025259 and lot code on the ST-AIA Pack BMG assay kit.
No, this recall is for potential false test results, not a safety hazard. The risk is low and does not involve physical harm.
Check the kit's Part Number and lot code. If affected, contact Tosoh Bioscience for guidance on next steps.
Inaccurate test results could lead to incorrect health conclusions, but the recall does not pose a direct risk to patients.
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-2098-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc Hello, I own a Tosoh Biosc: Inc that is covered by recall Z-2098-2018 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.
