Tosoh ST-AIA Pack C-Peptide Recall: False Test Results Risk

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Contact the company & request your remedy

Recalling firmTosoh Bioscience Inc3600 Gantz Rd, N/A · Grove City, OH 43123-1895

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Tosoh is recalling diabetes test kits that may give inaccurate results when used with a specific medication. This could lead to incorrect diabetes management decisions if the test results are relied upon.

Why it’s dangerous

The medication Asfotase Alfa (Strensiq) can interfere with certain diabetes test kits, causing them to show falsely high or low results. This might lead to incorrect diabetes management decisions if the test results are used without knowing the interference.

Who’s affected

People using the ST-AIA Pack C-Peptide test kits with part number 025284 for diabetes testing who are also taking Asfotase Alfa (Strensiq) medication. Those who rely on these test results for diabetes management are most at risk.

How to tell if you have this one

Check for the product name 'ST-AIA Pack C-Peptide' with part number 025284. All lot codes of this test kit are affected.

Brand
Tosoh Biosc: Inc
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Test Results
If you use this test kit with Asfotase Alfa (Strensiq) medication, verify results with a different test method to ensure accuracy.

✎ GovInfoNow

Questions people ask

Do I need to stop using this test kit?

No, but you should check results with another method if you take Asfotase Alfa (Strensiq) medication.

What part number is affected?

Part number 025284 for the ST-AIA Pack C-Peptide diabetes test kit.

Is there a fix for this issue?

The recall does not provide a specific fix; you should verify results with another test method.

Take action

Contact Tosoh Biosc: Inc

We’ve drafted a message you can send Tosoh Biosc: Inc to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2074-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc

Hello,

I own a Tosoh Biosc: Inc that is covered by recall Z-2074-2018 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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Where this comes from

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.

Official source: FDA Recall #Z-2074-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2074-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Tosoh Bioscience Inc recalls ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes

Lower-risk recall