Tosoh ST AIA-PACK Homocysteine Recall: In Vitro Diagnostic Use Only

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Contact the company & request your remedy

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Tosoh Bioscience is recalling all ST AIA-PACK Homocyste: Homocysteine (HCY) products designed for in vitro diagnostic use only. These products are used to measure homocysteine levels in blood tests. The recall is for safety reasons related to potential misuse.

Why it’s dangerous

The ST AIA-PACK Homocysteine (HCY) products are intended for in vitro diagnostic use only. They are not meant for direct human use. Misuse could lead to incorrect test results or safety issues.

Who’s affected

Healthcare professionals and labs using the ST AIA-PACK Homocysteine (HCY) products for in vitro diagnostics are affected. Those who have the products for clinical testing are at risk.

How to tell if you have this one

The product is labeled as ST AIA-PACK Homocysteine (HCY) for in vitro diagnostic use. All lots are included in this recall. Check if you have these products for blood tests.

Brand
Tosoh Bioscience
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the product name ST AIA-PACK Homocysteine (HCY) on the label.
Contact Manufacturer
Reach out to Tosoh Bioscience for further guidance on handling the recalled items.

✎ GovInfoNow

Questions people ask

Is this product safe for home use?

No, this product is designed for in vitro diagnostic use only and not for home use.

What should I do if I have this product?

Contact Tosoh Bioscience for instructions on handling the recalled items.

Are there any specific model numbers affected?

The recall covers all lots of ST AIA-PACK Homocysteine (HCY) products.

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-0675-2019 — Tosoh Bioscience Tosoh Bioscience

Hello,

I own a Tosoh Bioscience that is covered by recall Z-0675-2019 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-0675-2019 (November 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0675-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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 Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of

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