Alethia™ Group B Streptococcus
MERIDIAN BIOSCIENCE, INC. · Model 480350 · UDI-DI 00840733102196
Description
The Alethia Group B Streptococcus (GBS) assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth. The Alethia GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the Alethia GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections. The Alethia GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. Alethia Group B Streptococcus is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.
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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