Tosoh Bioscience recalls ST-AIA Cystatin C kidney marker assays due to potential false test results from Asfotase Alfa. Affected units include all lot codes of part number 025217.
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 Cystatin C kidney marker assays (part number 025217) may give false test results when used with Asfotase Alfa (Strensiq). This could lead to incorrect medical decisions if the test results are relied upon.
The assay may produce false high or low results when used with Asfotase Alfa. This could lead to incorrect medical decisions about kidney function if the test results are trusted.
Patients using these assays with Asfotase Alfa (Strensiq) for kidney marker testing. Those with kidney disease monitoring may be most at risk.
Check for the ST-AIA Cystatin C assay with part number 025217. All lot codes are affected. The product is used for kidney marker testing.
Verify if the assay was used with Asfotase Alfa (Strensiq) for kidney testing.
The recall may cause false results if used with Asfotase Alfa (Strensiq). Contact your healthcare provider for guidance.
Look for the ST-AIA Cystatin C assay with part number 025217 and all lot codes.
No action is required if the assay was not used with Asfotase Alfa. Check results with your healthcare provider.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-2099-2018 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-2099-2018 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.
