FDA Device recall Z-0943-2026
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
- FDA Device
- Class II
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class II recall of 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk by Copan Italia, citing treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0943-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-29 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Copan Italia |
| Distribution | CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT |
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.
Identifiers
| code_info | UDI:0U020N.A - (01)18053326005043 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Copan Italia
- 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-A…
FDA Device · Class II · 2025-12-24 · Copan Italia - BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
FDA Device · Class II · 2025-06-18 · Copan Italia - COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples
FDA Device · Class II · 2021-09-15 · Copan Italia - WASP (Walk Away Specimen Process)
FDA Device · Class III · 2013-09-11 · Copan Italia
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0943-2026%22
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