Copan Italia DTT Liquid Reagent Recall: Treatment Functionality Risk

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Recalling firmCopan ItaliaVia Francesco Perotti 10, 18 · Brescia, N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Copan Italia is recalling 1ml DTT reagents in PET tubes with capture caps because they may not work properly with respiratory specimens. This could lead to inaccurate test results if used in medical testing.

Why it’s dangerous

The reagent may not properly fluidify respiratory specimens, which could cause test results to be inaccurate. This is a functional issue with the reagent's performance in medical testing procedures.

Who’s affected

Healthcare professionals using this reagent for respiratory specimen testing are most at risk. Patients receiving tests with this reagent could potentially get inaccurate results.

How to tell if you have this one

Check for the product description: 1ml DTT in liquid phase, PET tube with capture cap. The unique identifier (UDI) is 0U020N.A - (01)1805332:26005043.

Brand
Copan Italia
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product by checking the unique identifier (UDI) 0U020N.A - (01)18053326005043 on the tube.

✎ GovInfoNow

Questions people ask

Why is this reagent being recalled?

The reagent may not properly fluidify respiratory specimens, which could lead to inaccurate test results.

How can I tell if I have the recalled product?

Look for the product description: 1ml DTT in liquid phase, PET tube with capture cap, with UDI 0U020N.A - (01)18053326005043.

What should I do if I have this product?

The recall record does not specify a remedy, so contact Copan Italia for guidance.

Take action

Contact Copan Italia

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

✉️ Open in email

Subject: Recall Z-0943-2026 — Copan Italia Copan Italia

Hello,

I own a Copan Italia that is covered by recall Z-0943-2026 from Copan Italia.

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-0943-2026 (October 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0943-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.

Copan Italia recalls 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk

Lower-risk recall