Recall Z-2508-2021

Reason for recall

Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute

FDA-determined cause: No Marketing Application

Action taken

On 08/06/2021, the firm sent an initial "URGENT MEDICAL DEVICE RECALL" Notification informing its customers that due insufficient evidence the firm was not issued an Emergency Use Authorization for its SARS-CoV-2 IgG (1st IS) assay and required to discontinue distribution and to recall all affected products. On 09/13/2021 the firm sent a revised "URGENT MEDICAL DEVICE RECALL UPDATE" to inform its customers about the potential risks/harms related to using the affected products, such as, the assay may generate discordant results such as false positive, false negative or misinterpreted results when compared to other World Health Organization (WHO) traceable assays. Customers are instructed to: 1. Immediately discontinue using the Access SARS-CoV-2 IgG (1st IS) assay. 2. Discard all Access SARS-CoV-2 (1st IS) reagent packs, calibrators, and quality control. 3. A retrospective review of patient test results obtained with the Access SARS-CoV-2 IgG (1st IS) assay is not required. Any review is left to the discretion of the Laboratory Medical Director. 4. Share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. 5. If any of the affected products have been forwarded to another laboratory, provide them with the notification. 6. Complete and return the Customer Response Form within 10 days electronically via email or manually via mail 7. For credit for the affected products, complete the Customer Response Form For questions, contact Customer Support Center via: Website - http://www.beckmancoulter.com Phone - 1-800-854-3633 in the United States