Summary
The FDA issued a Class II for ARIES SARS-CoV-2 Assay, REF: 50-10047 by Luminex Corporation. Reason: A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay .
Details
Source
Device Recall
External ID
Z-0134-2023
Action Date
2022-11-02
Status
Ongoing
Category
device
Product Description
ARIES SARS-CoV-2 Assay, REF: 50-10047
Lot/Code Info: Lot - Expiration: AB4723A - 05/25/2022, AB5041A - 05/25/2022, AB5060A - 06/01/2022, AB5061A - 06/06/2022, AB5081A - 06/07/2022, AB5139A - 09/10/2022, AB5141A - 09/16/2022, AB5263A - 09/27/2022, AB5282A - 10/05/2022, AB6640A - 06/8/2023, AB6720A - 06/13/2023
Quantity Affected: 5,141 (24 Cassettes)
Reason for Recall
A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.
Distribution
Distribution US nationwide, Indonesia, and Hong Kong.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-14
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 128 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-0134-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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