Group B strep test kits recalled over buffer caps missing gaskets
Meridian Bioscience is recalling Group B Streptococcus nucleic acid amplification test assays because the reaction buffer tube cap may be missing its rubber gasket.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 Group B Streptococcus 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 00840733102196, from lot 480350U020 expiring 12 June 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 the affected lot should follow Meridian's instructions.
The recalled product
- Product
- Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
- Manufacturer
- Meridian Bioscience Inc
- Category
- Medical Device — Diagnostic test
- Affected units
- 109
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 (3)
- UDI/DI 00840733102196
- Lot Numbers: 480350U020
- Exp. 2026-06-12
Distribution
Part of a larger recall action
This product is one of 2 recalled by Meridian Bioscience Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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