Home › Device types › NJR
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
FDA product code NJR · Class 1 · Microbiology
72
Registered devices
79
Adverse events
11
Recalls
18
510(k) clearances
Devices with this code
GeneXpert Dx System — CEPHEIDGeneXpert Dx System — CEPHEIDXpert® — CEPHEIDPanther Fusion® — Hologic, Inc.SmartCycler Dx System — CEPHEIDSmartCycler Dx System — CEPHEIDBD MAX™ GBS — BECTON, DICKINSON AND COMPANYBD MAX™ System — BECTON, DICKINSON AND COMPANYGeneXpert Dx System — CEPHEIDSimplexa™ GBS Positive Control Pack — DIASORIN MOLECULAR LLCSmartCycler Dx System — CEPHEIDGroup B Strep Assay — GREAT BASIN SCIENTIFIC, INC.SmartCycler Dx System — CEPHEIDSmartCycler Dx System — CEPHEIDGeneXpert Dx System — CEPHEIDSmartCycler Dx System — CEPHEIDSmartCycler Dx System — CEPHEIDSmartCycler Dx System — CEPHEIDRevogene GBS LB — MERIDIAN BIOSCIENCE, INC.SmartCycler Dx System — CEPHEIDSmartCycler Dx System — CEPHEIDPanther Fusion® — Hologic, Inc.GeneXpert® — CEPHEIDPanther Fusion® — Hologic, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-07 | Meridian Bioscience Inc | The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. |
| 2024-12-19 | Becton Dickinson & Co. | Potential for signal drift in specific lots of BD PCR Cartridges. |
| 2024-12-13 | Hologic, Inc. | Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment. |
| 2022-03-18 | Hologic, Inc | Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results. |
| 2019-02-20 | Luminex Corporation | Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, re |
| 2015-11-23 | Biomerieux Inc | FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States. |
| 2013-05-31 | Becton Dickinson & Co. | Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled. |
| 2012-12-11 | Becton Dickinson & Co. | Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs. |
| 2012-09-18 | Becton Dickinson & Co. | Clinical diagnostic instrument may exhibit minor defects, which could lead to erroneous test results. |
| 2011-04-01 | Cepheid | A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridge |
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