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U.S. Department of Health and Human Services

Class 2 Device Recall Status COVID19/Flu Rapid Immunoassay

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  Class 2 Device Recall Status COVID19/Flu Rapid Immunoassay see related information
Date Initiated by Firm July 27, 2021
Create Date September 03, 2021
Recall Status1 Terminated 3 on April 10, 2024
Recall Number Z-2410-2021
Recall Event ID 88429
Product Classification COVID-19 Multi-Analyte Antigen Device - Product Code QMN
Product Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Emergency use of this test is limited to authorized laboratories. (CLIA Waived Laboratories)
Code Information all lot codes
Recalling Firm/
Manufacturer		 Versea Diagnostics LLC
1000 N Florida Ave
Tampa FL 33602-3808
For Additional Information Contact Stephen Porada
800-397-0670
Manufacturer Reason
for Recall		 Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Versea Diagnostics, LLC began distributing their "URGENT MEDICAL DEVICE RECALL" notices dated 7/14/2021 to their direct consignee on 7/27/2021 by email. The notices instructed the customers immediately discontinue use of these test and quarantine, discard, return, or destroy any unused tests. Confirm any results from these tests using a different EUA authorized test. Discontinue the use of these products if you do not hold the required CLLIA status. Acknowledge your receipt of this notice by completing the attached Response Form, scanning and emailing the completed form to: compliance@versea.com. VERS¿A Diagnostics, LLC will work with its Customers to either: ¿ Affirm their customers authorization to use these products through their CLIA Number and Status ¿ Coordinate the return of unused, unopened products to VERS¿A Diagnostics, LLC The distributors were directed to notify their customers. The firm is seeking return of unused products. If you have questions, please call 800-397-0670 or email us at compliance@versea.com. We are available Monday through Friday from 8:00 AM to 4:00 PM Eastern Time.
Quantity in Commerce 563,290 in total
Distribution US Nationwide Distribution: AL, AZ, CA, CO, CT, FL, GA, IL, KS, OH, OK, MA, MD, MI, NC, NJ, NY, PA, SC, TX, VA, and WA.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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