Tosoh HbA1c Reagent Recall: Erroneous Blood Sugar Results Risk

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Contact the company & request your remedy

Recalling firmTosoh Bioscience Inc3600 Gantz Rd · 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 is recalling HbA:1c reagents that might give incorrect blood sugar readings. This could lead to improper diabetes treatment decisions if used without correction.

Why it’s dangerous

The reagent may produce either too high or too low HbA1c results. This could cause incorrect diabetes management decisions if the results are used without verification.

Who’s affected

People using the Tosoh ST AIA-PACK HbA1c reagent for diabetes testing. Those with diabetes who rely on accurate HbA1c results are most at risk.

How to tell if you have this one

The product is labeled as Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, with part number 025218. All lots of this product are affected.

Brand
Tosoh
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the part number 025218 on the reagent packaging.

✎ GovInfoNow

Questions people ask

Is this recall affecting my diabetes testing?

Yes, if you use the Tosoh ST AIA-PACK HbA1c reagent with part number 025218, it may give inaccurate HbA1c results.

How can I tell if I have the recalled product?

The product is labeled as Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, with part number 025218. All lots are affected.

What should I do if I have this product?

Check the product label for part number 025218. If you have it, you may need to verify results with another test method.

Take action

Contact Tosoh

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

✉️ Open in email

Subject: Recall Z-1809-2018 — Tosoh Tosoh

Hello,

I own a Tosoh that is covered by recall Z-1809-2018 from Tosoh.

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-1809-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1809-2018 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 Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the

Lower-risk recall