Recall archive / FDA device enforcement
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk — FDA record Z-0943-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 29, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Copan Italia
- Quantity
- 122,850 units US
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0943-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI:0U020N.A - (01)18053326005043 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 24, 2025
- Recall initiation date
- Oct 29, 2025
- Center classification date
- Dec 18, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.