[pending] Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test A
Pending LLM rewrite. Source: FDA_DEVICE Z-0568-2026.
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
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
The recalled product
- Product
- Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
- Manufacturer
- Meridian Bioscience Inc
- 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 (5)
- UDI/DI 00840733102172
- Lot Numbers: 480050U036
- Exp. 2026-08-01
- 480050U037
- Exp. 2026-09-04
Distribution
Distributed in 14 states:
- AL
- CO
- FL
- GA
- IL
- MD
- ME
- MT
- NH
- NJ
- OH
- TN
- TX
- WA
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