Z-0942-2026Class II

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

Name: Z-0942-2026 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP*...
Creator: Copan Italia
Published: 2025-10-29
License: https://open.fda.gov/license/

Copan Italia / initiated 2025-10-29 / Open, Classified

FDA source

Copan Italia began a recall of 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... on 2025-10-29. FDA classified it as Class II and gives the reason as "Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0942-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-29
Posted: 2025-12-18
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
Product code: PPM General Purpose Reagent
Reason for recall: Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
FDA 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 in commerce: 122,850 units US
Distribution: US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
Product codes and lots: UDI:0U020N.A - (01)18053326005036

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0942-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0942-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0943-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18

Product code PPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)