San Jose, CA, United States
VISBY MEDICAL INC recalls
1 recall recorded since 2018, most recently on 5 December 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 5 December 2020
- Terminated
- 7 January 2022
- 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.
- Distribution
- U.S. Nationwide distribution including in the states of CA, DC, FL, GA, MD, MN, MT, VA, and WA. O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0847-2021
- 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 U
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.