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Open, Classified

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

FDA Recall Z-0942-2026 · Posted 2025-12-18

Recalling FirmCopan Italia
Recall StatusOpen, Classified
Product CodePPM
Date Initiated2025-10-29
Product Quantity122,850 units US

Reason for Recall

Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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