Class 2 Device Recall CareStart COVID19 Antigen Rapid Diagnostic Test

• Date Initiated by Firm: July 27, 2021
• Create Date: September 03, 2021
• Recall Status: Terminated on April 10, 2024
• Recall Number: Z-2407-2021
• Recall Event ID: 88429
• Product Classification: Coronavirus antigen detection test system. - Product Code QKP
• Product: CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. (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: 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. VERSA 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 VERSA 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.