Summary
The FDA issued a Class II for ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 by Luminex Corporation. Reason: Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect result.
Details
Source
Device Recall
External ID
Z-0553-2022
Action Date
2022-02-09
Status
Terminated
Category
device
Product Description
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Lot/Code Info: Lot Numbers AB3600A and AB3560A
Quantity Affected: 329
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.
Distribution
Worldwide distribution - US Nationwide distribution in the states of New Jersey, California, Connecticut, Minnesota, Missouri, New Jersey, New Mexico, Pennsylvania, Tennessee, Washington, and Wisconsin) and the country of Malaysia.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-17
Company
Austin, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 95 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Luminex Corporation has 26 FDA actions in our database, including 21 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Luminex Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Luminex Corporation have FDA actions?
Luminex Corporation has 26 FDA actions in our database, including 21 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0553-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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