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U.S. Department of Health and Human Services

Class 2 Device Recall ARIES SARSCoV2 Assay

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  Class 2 Device Recall ARIES SARSCoV2 Assay see related information
Date Initiated by Firm July 14, 2022
Create Date August 17, 2022
Recall Status1 Open3, Classified
Recall Number Z-1524-2022
Recall Event ID 90698
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
Product ARIES SARS-CoV-2 Assay
Code Information Lot: AB4042A
Recalling Firm/
Luminex Corporation
12212 Technology Blvd
Austin TX 78727-6101
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
Nonconforming Material/Component
Action On 7/14/22 recall notices were emailed to consignees who were asked to review any results from the affected lot to confirm the validity of the results. In addition, all remaining cassettes from this lot should be discarded. Customers with questions are encouraged to contact the firm at: 1-877-785-2323 (U.S. and Canada), +1-512-381-4397 (Outside U.S. and Canada), support@luminexcorp.com
Quantity in Commerce 257
Distribution U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.