1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with C

FDA device recall Z-0942-2026 · posted 2025-12-18 · Open, Classified

Recall details

Recalling firm

Copan Italia

Reason for recall

Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

PPM

Quantity affected

122,850 units US

Distribution

US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT

Date initiated

2025-10-29

Date posted

2025-12-18

Location

Brescia, Italy