Recall Z-0553-2022— Luminex Corporation

Name: FDA recall Z-0553-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-17

Class II · Terminated

Class II FDA medical device recall by Luminex Corporation, initiated 2021-11-17, terminated 2024-07-08. It names one FDA 510(k) clearance: K161495. Product: ARIES HSV 1&2 Assay, Catalog/REF# 50-10017. Reason: Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid..

Recalling firm: Luminex Corporation
Classification: Class II
Status: Terminated
Initiated: 2021-11-17
Terminated: 2024-07-08
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K161495 — ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)Luminex Corporation·cleared 2016-06-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

Reason for recall

Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.

Data sourced from openFDA. This site is unofficial and independent of the FDA.