FDA Device recall Z-0569-2026
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
- FDA Device
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay by Meridian Bioscience, citing the cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0569-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-07 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Meridian Bioscience |
| Distribution | AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX, WA |
Product
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Reason
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Identifiers
| code_info | UDI/DI 00840733102196, Lot Numbers: 480350U020, Exp. 2026-06-12 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0569-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.