Class 2 Device Recall visby medical COVID19 Test kit

• Date Initiated by Firm: December 05, 2020
• Create Date: January 12, 2021
• Recall Status: Terminated on January 07, 2022
• Recall Number: Z-0847-2021
• Recall Event ID: 87049
• Product Classification: Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
• Product: visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization.
• Code Information: Part Number: PS-001442 Lot Numbers: LN20100067 LN20100148 LN20110040 LN20110213 WR20100003 Emergency Use Authorization (EUA202677)
• Recalling Firm/ Manufacturer: VISBY MEDICAL INC; 3010 N 1st St; San Jose CA 95134-2023
• For Additional Information Contact: 833-468-4729
• Manufacturer Reason for Recall: Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that expires prior to the expiration date on the test kits.
• FDA Determined Cause: Process control
• Action: On or about 12/07/2020, the firm contacted via telephone its customers and sent an "URGENT *** Recall and Field Corrective Action" Notification Letter via overnight courier informing them of the two issues pertaining to 5 specific lots of their test kits. The issues are: 1) Expiration Date: Visby COVID-19 Test kits lots LN20100067, LN20100148, LN20110040, have an expiration date on the outer kit boxes that matches the expiration date of the Visby COVID-19 devices contained in the foil pouch test kits. However, the outer kit boxes also contains Visby Dilution Kits with a shorter expiration date. The expiration dates of the affected test kits, Visby COVID-19 devices and Visby Dilution Kits are listed in the following table. While the Visby Dilution Kit packaging is labeled with the correct expiration date, the test kit labeling extends beyond the expiration date of the buffer within the Dilution Kit. The buffer should not be used beyond the expiration date on the Visby Dilution Kit label. 2) CLIA Waiver labeling: The outer kit boxes of all Visby COVID-19 Test kits shipped prior to December 4, 2020, were incorrectly labeled as CLIA waived. The Visby Medical COVID-19 test authorization is limited to use in CLIA moderate and high complexity laboratories. The image below reflects the incorrect labeling. The package insert and other labeling included with the Visby test kit correctly identify these test kits as for use in CLIA moderate and high complexity laboratories. The health risks associated with the two issues: A. Expiration Date: If any patients were tested after the buffer expiration date, there is a potential increased risk of false negative test results. Tests performed prior to the expiration date of the Visby Dilution Buffer are valid and unaffected by this issue. B. CLIA Waiver labeling: There is no impact to patient results related to the incorrect CLIA Waiver labeling. Customer s are instructed to: A. Expiration Date: For Device Lots affected by
• Quantity in Commerce: Total = 282 kits
• Distribution: U.S. Nationwide distribution including in the states of CA, DC, FL, GA, MD, MN, MT, VA, and WA. O.U.S.: None
• 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.