Recall Z-0847-2021— VISBY MEDICAL INC
Class II · Terminated
Class II FDA medical device recall by VISBY MEDICAL INC, initiated 2020-12-05, terminated 2022-01-07. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- VISBY MEDICAL INC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-12-05
- Terminated
- 2022-01-07
- Firm location
- San Jose, CA, United States
Product 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.