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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Copan Italia Respiratory Treatment Reagents Recalled for Functional Issues

Agency Publication Date: December 18, 2025
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Summary

Copan Italia is recalling approximately 122,850 units of their 1ml DTT liquid phase treatment reagents used for processing respiratory specimens. These reagents are used in laboratory settings to liquify or fluidify specimens for analysis and were distributed both in bulk and as part of systems compatible with the WASP (Walk-Away Specimen Processor). The manufacturer is initiating this recall because the functionality of the treatment reagent cannot be guaranteed, which could lead to laboratory errors.

Risk

The failure of the treatment reagent to properly liquify respiratory specimens may interfere with the fluidification process required for laboratory analysis. This could potentially result in inaccurate test results or delays in medical diagnosis for patients with respiratory conditions.

What You Should Do

  1. This recall affects Copan Italia 1ml DTT liquid phase treatment reagents in PET tubes with capture caps, including those sold in bulk or with sputum transfer devices for use with WASP systems. Affected products carry UDI codes (01)18053326005036 or (01)18053326005043.
  2. Stop using the recalled product immediately.
  3. Contact Copan Italia or your distributor to arrange for a return, replacement, or correction of the affected units.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

📋Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP
UDI:
(01)18053326005036

Compatible with Copan's WASP (Walk-Away Specimen Processor for Microbiology) System

Product: 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
UDI:
(01)18053326005043

Product Images

“Front label, DEVI Cinnamon Powder, 3.5 oz.”

“Front label, DEVI Cinnamon Powder, 3.5 oz.”

“Back label, Nutrition Facts”

“Back label, Nutrition Facts”

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97961
Status: Active
Manufacturer: Copan Italia
Sold By: Authorized distributors
Manufactured In: Italy
Units Affected: 2 products (122,850 units US)
Distributed To: California, Colorado, Florida, Georgia, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.