Revogene® GBS LB
Meridian Bioscience Canada Inc · Model 410200 · UDI-DI 00628055344117
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 |
|---|---|---|
| 2025-03-20 | Abbott Molecular, Inc. | The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the foot |
| 2024-12-10 | Biocartis Nv | False-positive MSI-H results generated by the Idylla MSI Test. |
| 2024-03-20 | Abbott Molecular, Inc. | The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the me |
| 2024-02-01 | Abbott Molecular, Inc. | Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers. |
| 2023-12-15 | Hologic, Inc. | Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. |
| 2023-06-14 | DiaSorin Molecular LLC | There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc. |
| 2022-12-09 | Abbott Molecular, Inc. | The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have |
| 2022-11-11 | Abbott Molecular, Inc. | The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returne |
| 2022-10-12 | Abbott Molecular, Inc. | Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when th |
| 2022-06-22 | Meridian Bioscience Inc | When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated |
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