RECALLS & FIELD CORRECTIONS—CLASS II
Visby Medical COVID-19 Test Kit
Company: Visby Medical Inc, 3010 N 1st St, San Jose, CA 95134; Ph.: 833-468-4729.
Recall began: December 5, 2020.
Device(s): Visby Medical COVID-19 Test Kit (Recall # Z-0847-2021).
Reason for recall: There are 2 issues: 1) 5 lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived; and 2) 3 lots contain a kit component that expires before the expiration date on the test kits.© 2021 Wolters Kluwer Health, Inc. All rights reserved.