Class II U.S. Food and Drug Administration

Copan Italia 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk recall: Treatment reagent functionality in respiratory specimens fluidification

Recall published 10 months ago

Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0943-2026
Published
December 24, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Copan Italia
Product type
Medical devices
Units affected
122,850 units US
Distribution
California, Colorado, Florida, Georgia, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah
Made in
Italy
Lot / code info
UDI:0U020N.A - (01)18053326005043
UPC codes
18053326005043

Products covered by this recall

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

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 18053326005043

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 ml

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Copan Italia — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Copan Italia — Via Francesco Perotti 10, 18, Brescia

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Copan Italia medical devices recalled?

Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed. Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 18053326005043. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists California, Colorado, Florida, Georgia, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Tennessee and others.

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