FDA-Device2025-12-24Class IIPROCESSING DEFECT
Copan Italia DTT reagent recalled for potential respiratory specimen processing failure
Stop using Copan Italia DTT treatment reagent
Copan Italia's DTT (dithiothreitol) liquid reagent, used to prepare respiratory specimens in laboratories, may not work properly. The reagent is supplied in 1ml PET tubes with capture caps. There have been no reported injuries, but the functionality cannot be guaranteed for specimen fluidification.
- Stop using affected DTT reagent tubes (UDI: 0U020N.A)
- Contact your laboratory supplier or Copan Italia for a replacement or refund
- Review any respiratory specimen results processed with this reagent batch
Hazard
Treatment reagent functionality in respiratory specimens fluidification 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0943-2026Don't want to check this manually?
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