Tosoh Bioscience recalls ST-AIA Myoglobin assay kits (part #025297) due to potential false test results when used with Asfotase Alfa (Strensiq). 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 ST-AIA Myoglobin assay kits (part number 025297) 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 relied on.
The assay kits can produce inaccurate test results when used with Asfotase Alfa medication. This might cause doctors to make wrong medical decisions based on false high or low readings of cardiac markers.
Patients using Asfotase Alfa (Strensiq) medication who run these specific myoglobin assays may be affected. Those with cardiac markers tests using the recalled kits are most at risk.
Check for the ST-AIA Myoglobin assay kit with part number 025297. All lot codes are affected by this recall.
Identify the product by checking the part number (025297) and lot code on the kit.
The assay kits can produce false high or low results when used with Asfotase Alfa (Strensiq) medication, potentially leading to incorrect medical decisions.
No specific stop-use instruction is provided; the recall focuses on identifying affected kits for potential correction.
The official recall notice does not specify a remedy or action beyond identifying the affected kits.
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-2072-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc Hello, I own a Tosoh Biosc: Inc that is covered by recall Z-2072-2018 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.
