Tosoh ST-AIA PACK Cort Recall: False Test Results Risk

Take action

Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Tosoh Bioscience is recalling ST-AIA PACK Cort (Part Number 025287) because it can cause false high or low test results in metabolic assays. This means lab tests might give incorrect results, which could affect diagnosis or treatment decisions.

Why it’s dangerous

The ST-AIA PACK Cort contains Asfotase Alfa (Strensiq) which can interfere with certain Tosoh metabolic assays. This interference may cause test results to be too high or too low, depending on the specific assay being used.

Who’s affected

Lab users and healthcare professionals who perform metabolic immunoassays with the ST-AIA PACK Cort. Those using the product for diagnostic testing are most at risk of inaccurate results.

How to tell if you have this one

Check for the product name 'ST-AIA PACK Cort' with Part Number 025287. All lot codes of this product are affected. The product is used in laboratory settings for metabolic immunoassays.

Brand
Tosoh Biosc: Inc
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify if your ST-AIA PACK Cort has Part Number 025287 and is used in metabolic immunoassays.

✎ GovInfoNow

Questions people ask

Does this recall affect home users?

No, this recall is for laboratory use only. Home users are not affected.

What happens if I have the recalled product?

The official recall notice does not specify a remedy or action for affected products.

Can this cause serious injury?

The recall describes potential false test results, not physical injury risks. This is a low-risk issue for lab accuracy.

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-2094-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc

Hello,

I own a Tosoh Biosc: Inc that is covered by recall Z-2094-2018 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-2094-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2094-2018 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 Cort; Part Number: 025287 Assay, Metabolic

Lower-risk recall