Recall database

Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–3 of 3 recalls

Class IIOngoingZ-0569-2026

Meridian Bioscience Inc recalls Meridian Bioscience

The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.

Meridian Bioscience In…OHNov 26, 2025

Class IIOngoingZ-1004-2025

Becton Dickinson & Co. recalls BD PCR Cartridges used with MAX System. Model Number: 437519

Potential for signal drift in specific lots of BD PCR Cartridges.

Becton Dickinson & Co.MDJan 29, 2025

Class IIOngoingZ-0907-2025

Hologic, Inc. recalls Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartri…

Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.

Hologic, Inc.CAJan 22, 2025