← FDA ENFORCEMENT
Z-0943-2026Class II
Copan Italia
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Copan Italia
Product type
Device
Status
Ongoing
Report date
2025-12-24
Distribution
US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
Product quantity
122,850 units US
Initiated by
Voluntary: Firm initiated
Reason for recall
Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
Product description
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Code / lot info
UDI:0U020N.A - (01)18053326005043
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →