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ARIES® GBS Assay

LUMINEX CORPORATION · Model 50-10021 · UDI-DI 00840487100165

NJR Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The ARIES® GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant 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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.