Recall Z-0498-2022— Luminex Corporation

Name: FDA recall Z-0498-2022
Creator: U.S. Food and Drug Administration
Published: 2021-04-16

Class II · Terminated

Class II FDA medical device recall by Luminex Corporation, initiated 2021-04-16, terminated 2024-09-20. It names one FDA 510(k) clearance: K161495. Product: ARIES HSV 1&2 Assay, Part Number/REF 50-10017. Reason: Impacted lot may leak inside the ARIES instrument..

Recalling firm: Luminex Corporation
Classification: Class II
Status: Terminated
Initiated: 2021-04-16
Terminated: 2024-09-20
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, Part Number/REF 50-10017

Reason for recall

Impacted lot may leak inside the ARIES instrument.

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