Tosoh ST-AIA PACK IGE II Recall: False Test Results Risk

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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 Bioscience recalls allergy test kits (ST-AIA PACK IGE II, part number 025295) that could give false high or low results in certain tests. This affects all units sold with this part number, but no action is required per the recall notice.

Why it’s dangerous

The test kit contains Asfotase Alfa (Strensiq) which can interfere with certain Tosoh assays. This interference may cause test results to be too high or too low depending on the specific test being run.

Who’s affected

All users of Tosoh's allergy test kits with part number 025295 are affected. People using these kits for medical testing may be at risk of incorrect results.

How to tell if you have this one

Check for the part number 025295 on the ST-AIA PACK IGE II allergy assay kit. All lot codes of this product are affected.

Brand
Tosoh Biosc: Inc
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Look for the part number 025295 on the ST-AIA PACK IGE II allergy assay kit.

✎ GovInfoNow

Questions people ask

Do I need to do anything with this kit?

The official recall notice does not specify any action required for this product.

What could happen if I use this kit?

Using this kit may cause false high or low test results depending on the specific assay being run.

Is there a fix for this issue?

The recall notice does not mention any remedy or fix for this product.

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-2097-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc

Hello,

I own a Tosoh Biosc: Inc that is covered by recall Z-2097-2018 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-2097-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2097-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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 IGE II; Part Number: 025295 Assay, Allergy

Recall notice