Class 2 Device Recall ARIES SARSCoV2 Assay

• Date Initiated by Firm: July 14, 2022
• Create Date: August 17, 2022
• Recall Status: Open, 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/ Manufacturer: Luminex Corporation; 12212 Technology Blvd; Austin TX 78727-6101
• For Additional Information Contact: 512-219-8020
• 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: 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.