FDAClass IIJanuary 26, 2022

ARIES HSV 1&2 Assay recall

ARIES HSV 1&2 Assay, Part Number/REF 50-10017

Why was ARIES HSV 1&2 Assay recalled?

Impacted lot may leak inside the ARIES instrument.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number AB1703A

Product
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Recalling firm
Luminex Corporation
Quantity
296 kits
Distribution
Worldwide distribution - US Nationwide distribution in the states of Alabama, California, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the country of Taiwan.
Recall date
January 26, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls