FDA-Device2025-12-24Class IIPROCESSING DEFECT
Copan DTT reagent for WASP system recalled due to uncertain specimen liquification functionality
What this means
Copan Italia's DTT (dithiothreitol) reagent tubes used with the WASP microbiology system may not reliably liquefy respiratory specimens as intended. This could affect the quality of lab test results. The issue affects approximately 122,850 units distributed across multiple US states.
- Check if your lab has DTT reagent tubes with UDI 0U020N.A
- Stop using affected tubes and contact your lab supplier or Copan for replacement or guidance
- Review any patient test results processed with these tubes for potential impact
The agency's original wording
Hazard
Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT
Affected count
122,850 units US
Manufactured in
Via Francesco Perotti 10, 18, Brescia, Italy
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0942-2026Want us to check the next one for you?
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