Home › LUMINEX CORPORATION › ARIES® Flu A/B & RSV Assay

ARIES® Flu A/B & RSV Assay

LUMINEX CORPORATION · Model 50-10020 · UDI-DI 00840487100158

OZE OCC Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swabs (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings.

Recalls

Date	Firm	Reason
2026-02-09	Abbott Diagnostics Scarborough, Inc.	It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
2025-03-04	Abbott Diagnostics Scarborough, Inc.	the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
2025-03-04	Abbott Diagnostics Scarborough, Inc.	The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
2024-04-26	Centers For Disease Control and Prevention	The H5b component may fail to amplify, resulting in an inconclusive result.
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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.