Summary
The FDA issued a Class II for ARIES SARS-CoV-2 Assay by Luminex Corporation. Reason: SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected,.
Details
Source
Device Recall
External ID
Z-1524-2022
Action Date
2022-08-24
Status
Ongoing
Category
device
Product Description
ARIES SARS-CoV-2 Assay
Lot/Code Info: Lot: AB4042A
Quantity Affected: 257
Reason for Recall
SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.
Distribution
U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-14
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 132 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-1524-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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