Class 2 Device Recall Cellex qSARSCov2 Antigen Rapid Test

• Date Initiated by Firm: March 01, 2021
• Create Date: September 13, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2452-2021
• Recall Event ID: 88206
• Product Classification: Coronavirus antigen detection test system. - Product Code QKP
• Product: Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
• Code Information: All lot numbers
• Recalling Firm/ Manufacturer: Cellex; 507 Airport Blvd Ste 107; Morrisville NC 27560-8200
• Manufacturer Reason for Recall: The kit does not have an emergency use authorization (EUA).
• FDA Determined Cause: Under Investigation by firm
• Action: The recall was initiated via phone. The date the telephone calls were made is unknown but may have occurred late February, early March, 2021, based on the date returns started being made to the recalling firm. The firm issued their initial letters dated 6/15/2021 via email as a result of not having documentation of the phone calls. Later notifications were also issued or verbally discussed, with the latest notification occurring 8/20/2021.
• Quantity in Commerce: Approximately 44,821 kits
• Distribution: US Nationwide distribution in the states of CA, FL, TX, and WI.
• 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.