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Recall Observatory FDA recall evidence

Device 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

Z-0942-2026

October 29, 2025

Class II

Product summary

Firm
Copan Italia
Event
Event 97961
Status
Ongoing
Classification
Class II
Quantity
122,850 units US
Official record key
device-enforcement:Z-0942-2026

Official wording

Reason: Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.

Code information: UDI:0U020N.A - (01)18053326005036

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.