Copan Italia
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 8
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0942-2026 | Class II | 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP | October 29, 2025 |
| Z-0943-2026 | Class II | 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk | October 29, 2025 |
| Z-1937-2025 | Class II | BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx | May 2, 2025 |
| Z-2440-2021 | Class II | COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference num | July 9, 2021 |
| Z-2131-2013 | Class III | WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W0 | August 9, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K232565 | UriSponge | October 11, 2024 |
| K232357 | Copan Universal Transport Medium (UTM-RT) System | April 25, 2024 |
| K220052 | Copan FecalSwab Collection, Transport and Preservation System | December 16, 2022 |
| K201849 | eNAT molecular collection and preservation medium | September 17, 2020 |
| K180052 | UriSwab-Urine Collection, Transport and Preservation System | March 23, 2018 |
| K142094 | COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM | April 10, 2015 |
| K972448 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL | August 20, 1997 |
| K972449 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL | August 20, 1997 |