Copan Italia: Medical Device Recall in 2025 - (Recall #: Z-0943-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

1ml of DTT in liquid phase, in PET tube with capture cap, in bulk

Product Classification:

Class II

Date Initiated: October 29, 2025

Date Posted: December 24, 2025

Recall Number: Z-0943-2026

Event ID: 97961

Reason for Recall:

Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

Status: Ongoing

Product Quantity: 122,850 units US

Code Information:

UDI:0U020N.A - (01)18053326005043

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated