[pending] 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Pending LLM rewrite. Source: FDA_DEVICE Z-0943-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
The recalled product
- Product
- 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
- Manufacturer
- Copan Italia
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI:0U020N.A - (01)18053326005043
Distribution
Distributed in 14 states:
- CA
- CO
- FL
- GA
- MN
- MS
- NH
- NJ
- NY
- OH
- PA
- TN
- TX
- UT
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