Tosoh ST-AIA PACK PA Recall: False Assay 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 its ST-AIA PACK PA assay kit (Part Number 025263) because it can cause false high or low results in tumor marker tests. This could lead to incorrect health diagnoses if used with certain assays.

Why it’s dangerous

The ST-AIA PACK PA kit contains Asfotase Alfa (Strensiq), which can interfere with certain tumor marker assays. This interference may cause test results to be too high or too low, potentially leading to incorrect health assessments.

Who’s affected

Healthcare professionals using the ST-AIA PACK PA assay kit for tumor marker tests. Patients receiving lab results from this kit may be at risk of inaccurate diagnoses.

How to tell if you have this one

Check for the ST-AIA PACK PA assay kit with Part Number 025263. All lot codes are affected. This product is used in tumor marker testing.

Brand
Tosoh Biosc: Inc
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Identify the Part Number 025263 on the ST-AIA PACK PA assay kit.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The ST-AIA PACK PA kit contains Asfotase Alfa (Strensiq) which can interfere with certain tumor marker assays, causing false high or low test results.

What should I do if I have this kit?

Check the Part Number on the kit; if it's 025263, contact Tosoh Bioscience for guidance.

Is this dangerous?

This recall is for potential false test results, not immediate safety risks. The hazard level is low risk.

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-2067-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc

Hello,

I own a Tosoh Biosc: Inc that is covered by recall Z-2067-2018 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-2067-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2067-2018 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 PA; Part Number: 025263 Assay, Tumor Marker

Lower-risk recall