Tosoh ST-AIA PACK 27.29 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 ST-AIA PACK 27.2:29 (Part Number 025202) because it can cause false high or low results in certain tumor marker tests. This could lead to incorrect health assessments if used with Asfotase Alfa (Strensiq).

Why it’s dangerous

The ST-AIA PACK 27.29 can interfere with Asfotase Alfa (Strensiq) tests, causing false high or low results in tumor marker assays. This may lead to incorrect health assessments if the assay is used with the medication.

Who’s affected

Patients using Asfotase Alfa (Strensiq) and Tosoh ST-AIA PACK 27.29 for tumor marker testing are most at risk. Others using the assay may not be affected.

How to tell if you have this one

Check for the product name 'ST-AIA PACK 27.29' with Part Number 025202. All lot codes are affected.

Brand
Tosoh Bioscience
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product name and part number to confirm if it's affected.

✎ GovInfoNow

Questions people ask

Does this recall affect my Strensiq tests?

Yes, if you use the ST-AIA PACK 27.29 with Strensiq, it may cause false results.

What should I do if I have this product?

The recall does not specify a remedy, so check with your healthcare provider for guidance.

Is there a risk of serious injury?

The recall describes potential false test results, not physical injury risks.

Take action

Contact Tosoh Bioscience

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

✉️ Open in email

Subject: Recall Z-2070-2018 — Tosoh Bioscience Tosoh Bioscience

Hello,

I own a Tosoh Bioscience that is covered by recall Z-2070-2018 from Tosoh Bioscience.

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-2070-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2070-2018 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 27.29; Part Number: 025202 Assay, Tumor Marker

Lower-risk recall