FDA-Device2025-12-24Class IIPROCESSING DEFECT
Copan DTT reagent for WASP system recalled due to uncertain specimen liquification functionality
Stop using affected Copan DTT reagent tubes
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
Hazard
Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
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-0942-2026Don't want to check this manually?
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