# FDA recall Z-0943-2026

> **Copan Italia** · Class II · device recall initiated 2025-10-29.

## Product

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

## Reason for recall

Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

## Distribution

US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT

## Key facts

- **Recall number:** Z-0943-2026
- **Recalling firm:** Copan Italia
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-29
- **Report date:** 2025-12-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brescia, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0943-2026

## Citation

> AI Analytics. FDA recall Z-0943-2026. Retrieved 2026-09-21 from https://api.ai-analytics.org/recall/Z-0943-2026. Source: US FDA. Licensed CC0.

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