CLASS II ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report
Group B Streptococcus recalled by Meridian Bioscience
Meridian Bioscience is recalling Group B Streptococcus, distributed in 14 states. The recall was initiated on 7 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0569-2026
- FDA event ID
- 97787
- Recalling firm
- Meridian Bioscience, Cincinnati, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Oct 2025
- FDA classified
- 19 Nov 2025
- Reported
- 26 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Test Kits & Diagnostics
Timeline
| 7 Oct 2025 | Recall initiated by company | |
| 19 Nov 2025 | Classified by FDA | +43 days |
| 26 Nov 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Where it was distributed
US Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX and WA; and OUS (foreign) countries of: Canada, Italy, and Panama.
AlabamaColoradoFloridaGeorgiaIllinoisMarylandMaineMontanaNew HampshireNew JerseyOhioTennesseeTexasWashington
Questions about this recall
Why was it 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.
Which lots are affected?
UDI/DI 00840733102196, Lot Numbers: 480350U020, Exp. 2026-06-12
Where was it sold?
US Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX and WA; and OUS (foreign) countries of: Canada, Italy, and Panama.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97787This product is part of a recall event; the main page for the event is alethia c. Difficile recalled by Meridian Bioscience.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | alethia c. Difficile recalled by Meridian Bioscience | Meridian Bioscience | Foreign Material | 14 states |
More recalls from Meridian Bioscience
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Revogene C. difficile, in vitro diagnostic assay intended recalled | Meridian Bioscience | Potency & Assay | Nationwide |
| Device | CLASS II | alethia c. Difficile recalled by Meridian Bioscience | Meridian Bioscience | Foreign Material | 14 states |
| Device | CLASS II | Para-Pak Clean Vial-For the collection, transportation recalled | Meridian Bioscience | Foreign Material | Nationwide |
| Device | CLASS II | Para-Pak Zn-PVA/10% Formalin-for the routine collection recalled | Meridian Bioscience | Foreign Material | Nationwide |
| Device | CLASS II | Cardinal Health Clean Stool Transportation System recalled | Meridian Bioscience | Packaging Defects | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,663| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |