Recall Z-0943-2026— Copan Italia
Class II · Ongoing
Class II FDA medical device recall by Copan Italia, initiated 2025-10-29. FDA's recall record names no specific 510(k) clearance for this event. Product: 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk. Reason: Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed..
- Recalling firm
- Copan Italia
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-29
- Firm location
- Brescia, Italy
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.