C difficile test kits recalled over buffer caps missing a gasket
Meridian Bioscience is recalling alethia C. difficile nucleic acid amplification test assays because the reaction buffer tube cap may be missing its rubber gasket.
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: Scored 3 under the risk-of-harm criterion: leakage and reduced buffer volume can affect a diagnostic result, and no injuries are reported.
Plain-English summary
The Meridian Bioscience alethia C. difficile Nucleic Acid Amplification Test Assay, catalog number 480050, is being recalled.
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 recall covers 109 units in total across the affected assays, carrying UDI/DI 00840733102172, from lots 480050U036 (expiring 1 August 2026) and 480050U037 (expiring 4 September 2026). The product was distributed in Alabama, Colorado, Florida, Georgia, Illinois, Maryland, Maine, Montana, New Hampshire, New Jersey, Ohio, Tennessee, Texas and Washington, and internationally. The FDA has classified the action as Class II.
Reduced buffer volume can affect how the assay performs. The enforcement record reports no injuries. Laboratories holding affected lots should follow Meridian's instructions.
The recalled product
- Product
- Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
- Manufacturer
- Meridian Bioscience Inc
- Category
- Medical Device — Diagnostic test
- Hazard
- missing-gasket
- leakage
- assay-integrity
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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