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Copan Italia: 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

Medical DevicesSource: FDA (device) · Date: 2025-12-24

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
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
Reason / hazard
Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
Recall initiated
2025-10-29
Code info
UDI:0U020N.A - (01)18053326005036
Product quantity
122,850 units US
Voluntary mandated
Voluntary: Firm initiated
City
Brescia
Country
Italy
Event id
97961
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