The Recall Desk
HighFDA (Devices)·Z-0553-2022·Announced 2022-02-09

ARIES HSV 1&2 Diagnostic Cassettes May Leak, Affecting Test Results

Luminex Corporation is recalling ARIES HSV 1&2 Assay cassettes (lot numbers AB3600A and AB3560A) due to a confirmed 0.9% leak rate. Leaking cassettes may cause incorrect or delayed test results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a diagnostic device with a confirmed malfunction (0.9% leak rate) that could produce incorrect test results. Although no illnesses or injuries have been reported, the device presents a risk of causing diagnostic failures in clinical settings.

Plain-English summary

Luminex Corporation is recalling ARIES HSV 1&2 Assay cassettes (lot numbers AB3600A and AB3560A), Catalog/REF# 50-10017, a diagnostic test system for herpes simplex virus types 1 and 2. Testing has confirmed that affected cassettes may leak inside the ARIES instrument at a verified rate of 0.9%. Approximately 329 units have been distributed.

When a cassette leaks, it compromises test integrity. Leaking cassettes could result in incorrect test results or delayed result reporting, with outcomes marked as Invalid by the instrument.

The recalled product has been distributed worldwide, including to healthcare facilities in the following U.S. states: New Jersey, California, Connecticut, Minnesota, Missouri, New Mexico, Pennsylvania, Tennessee, Washington, and Wisconsin. International distribution includes Malaysia.

The recalled product

Product
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Manufacturer
Luminex Corporation
Category
Medical Device — Diagnostic Test System
Hazard
  • cassette-leak
  • invalid-test-results

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers AB3600A and AB3560A

Distribution

Distributed nationwide across the United States.

Related recalls

Same category