1ml of DTT in liquid phase — Class II medical device recall Z-0943-2026
Ongoing recall by Copan Italia, reported 2025-12-24, distributed in CA, CO, FL, GA, MN, MS, NH, NJ…. Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
| Recall number | Z-0943-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Copan Italia, Brescia, Italy |
| Recall initiated | 2025-10-29 |
| Classified | 2025-12-18 |
| Reported by FDA | 2025-12-24 |
| Distributed | CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT |
| Quantity | 122,850 units |
| UPC / GTIN / UDI-DI | 18053326005043 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0943-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.