Tosoh Bioscience recalls ST-AIA CK-MB cardiac marker assays (part 025269) due to potential false test results with Asfotase Alfa. 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 Biosc: ST-AIA CK-MB cardiac marker assays (part number 025269) are recalled because they can give false high or low results when used with Asfotase Alfa medication. This could lead to incorrect medical decisions if the test results are not properly interpreted.
The assay can produce inaccurate results when used with Asfotase Alfa medication. This might cause doctors to make incorrect medical decisions based on the test results.
Patients using Asfotase Alfa (Strensiq) medication who run these cardiac marker tests may be affected. Those with cardiac markers tests done by labs using the recalled assay are most at risk.
Check for the ST-AIA CK-MB assay with part number 025269. All lot codes are affected, so the product is recalled regardless of when it was purchased.
Look for the ST-AIA CK-MB assay with part number 025269 on your test kit.
The assay can give false high or low results when used with Asfotase Alfa medication, potentially leading to incorrect medical decisions.
No, but you should check if you have the recalled assay and contact your lab for guidance.
The recall record does not mention a fix or remedy.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-2071-2018 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-2071-2018 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.
