Tosoh ST-AIA PACK AFP 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 is recalling ST-AIA PACK AFP assay kits because they can give false high or low results when used with Asfotase Alfa (Strensiq) tests. This could lead to incorrect health decisions if the tests are relied on.

Why it’s dangerous

The ST-AIA PACK AFP assay kits can produce false high or low results when used with Asfotase Alfa (Strensiq) tests. This happens because the medication interferes with the assay process, potentially leading to inaccurate tumor marker measurements.

Who’s affected

Patients using Asfotase Alfa (Strensiq) treatments who run these assays may be affected. Those with specific tumor marker tests are most at risk of incorrect results.

How to tell if you have this one

Check for the ST-AIA PACK AFP assay kit with Part Number 025252. All lot codes are affected by this recall.

Brand
Tosoh Biosc: Inc
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Assay Kit Details
Identify the Part Number 025252 and all lot codes of the ST-AIA PACK AFP assay kit.

✎ GovInfoNow

Questions people ask

Do I need to stop using these kits?

The recall does not require stopping use; it only warns about potential false results with Asfotase Alfa tests.

How do I know if my kit is affected?

All ST-AIA PACK AFP assay kits with Part Number 025252 are affected, regardless of lot code.

What should I do if I have these kits?

The recall does not specify a remedy, so no action is required beyond checking if you have the affected kits.

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-2065-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc

Hello,

I own a Tosoh Biosc: Inc that is covered by recall Z-2065-2018 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-2065-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2065-2018 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 AFP; Part Number: 025252 Assay, Tumor Marker

Lower-risk recall