FDA-Device2025-12-24Class IIPROCESSING DEFECT
Copan Italia DTT reagent recalled for potential respiratory specimen processing failure
What this means
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
The agency's original wording
Hazard
Treatment reagent functionality in respiratory specimens fluidification 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0943-2026Want us to check the next one for you?
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