FDA Medical Device Recalls (openFDA)
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-Away Specimen Processor for Microbiology) System
- Recall number
- Z-0942-2026
- Recalling firm
- Copan Italia
- Product
- 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-Away Specimen Processor for Microbiology) System
- Status
- Open, Classified
- Initiated
- 2025-10-29
- Posted
- 2025-12-18
- Terminated
- not on file
- Reason
- Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
- Root cause
- Under Investigation by firm
- Action
- On October 29, 2025, Copan initiated a Urgent: Medical Device Recall Notification via Email to affected consignees Copan ask consignees to take the following actions: 1. Further distribution or use of the remaining product must stop immediately: trace and dispose of all affected products. 2. This notice should be passed on to all those who need to be aware within your organization. 3. Ensure that the same obligations (communication to end users and related evaluation activities) are guaranteed by any additional Customer. In particular, if you have further distributed the devices, please provide those Customers a copy of the recall notification and response form. 4. Confirm you have read and understood the recall instructions provided in the letter, in writing. If you have any questions, call Chief Operating Officer, at 030-2687211.
- Quantity
- 122,850 units US
- Distribution
- US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
- Lot, serial or model codes
- UDI:0U020N.A - (01)18053326005036
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PPM
- Firm FEI
- 3002444944
- Firm city
- Brescia
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28