Tosoh Bioscience recalls diabetes assay kits with part number 025260 due to potential false test results when used with Asfotase Alfa (Strensiq). Affected lots may cause inaccurate diabetes test outcomes.
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 diabetes assay kits (part number 025260) because they can give false high or low results when used with Asfotase Alfa medication. This could lead to incorrect diabetes management decisions if the test results are relied upon.
The assay kit can produce false high or low results when used with Asfotase Alfa medication. This happens because the medication interferes with the test's chemical process. Inaccurate results could lead to incorrect diabetes management decisions.
People using the ST-AIA PACK IRI diabetes assay kit with part number 025260 and Asfotase Alfa (Strensiq) medication. Those managing diabetes with these tests are most at risk of inaccurate results.
Check for the part number 025260 on the ST-AIA PACK IRI diabetes assay kit. All lot codes are affected. The product is sold under the brand Tosoh Bioscience.
Look for part number 025260 on the ST-AIA PACK IRI diabetes assay kit. All lot codes are affected.
The assay kit can produce false high or low results when used with Asfotase Alfa (Strensiq) medication, which could lead to incorrect diabetes management decisions.
Check for part number 025260 on the ST-AIA PACK IRI diabetes assay kit. All lot codes are affected.
The recall record does not specify a remedy or action for the product. Check with Tosoh Bioscience for further guidance.
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-2076-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc Hello, I own a Tosoh Biosc: Inc that is covered by recall Z-2076-2018 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.
