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.
Recall
- Recall Number
- Z-0847-2021
- Event Number
- 87049
- Firm
- VISBY MEDICAL INC
- FEI Number
- 3016608638
- Product Code
- QJR
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 5, 2020
- Terminated
- January 7, 2022
- Address
- 3010 N 1st St, San Jose, CA, 95134-2023
Description
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.
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.
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
U.S. Nationwide distribution including in the states of CA, DC, FL, GA, MD, MN, MT, VA, and WA. O.U.S.: None
Total = 282 kits