Tosoh ST-AIA Pack Fer Recall: False Anemia Test 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 Fer assay kit (Part Number 025253) because it can cause inaccurate anemia test results when used with certain blood tests. This could lead to incorrect health decisions if the test results are not properly interpreted.

Why it’s dangerous

The ST-AIA Pack Fer assay kit can interfere with certain blood tests, causing false high or low readings for anemia. This might lead to incorrect health decisions if the test results are not properly interpreted.

Who’s affected

Users of the ST-AIA Pack Fer assay kit (Part Number 025253) for anemia testing. Those who rely on this kit for blood tests may be at risk of inaccurate results.

How to tell if you have this one

Check for the ST-AIA Pack Fer assay kit with Part Number 025253. All lot codes are affected by this recall.

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 025253 on the ST-AIA Pack Fer assay kit.

✎ GovInfoNow

Questions people ask

Why is this kit being recalled?

The ST-AIA Pack Fer assay kit can cause false high or low anemia test results when used with certain blood tests.

What should I do if I have this kit?

The recall does not specify a remedy, so contact Tosoh Bioscience for guidance.

Is there a risk of serious injury?

The recall indicates potential inaccurate test results, not a direct risk of injury.

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-2096-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc

Hello,

I own a Tosoh Biosc: Inc that is covered by recall Z-2096-2018 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-2096-2018 (March 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2096-2018 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 Fer; Part Number: 025253 Assay, Anemia

Lower-risk recall