Revogene GBS LB
MERIDIAN BIOSCIENCE, INC. · Model 410200 · UDI-DI 00840733102363
Description
The Revogene GBS LB assay performed on the Revogene Instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM Broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes Automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. it is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
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, resulting in partially |
| 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 cartridges are introduced in |
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