DTT Respiratory Specimen (Copan) – Reagent Functionality Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Copan Italia Via Francesco Perotti 10
Lot Codes / Batch Numbers
UDI:0U020N.A - (01)18053326005036
Products Sold
UDI:0U020N.A - (01)18053326005036
Copan Italia Via Francesco Perotti 10 is recalling 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP due to Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
Page updated: Jan 10, 2026