# FDA recall Z-0847-2021

> **VISBY MEDICAL INC** · Class II · device recall initiated 2020-12-05.

## 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 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.

## Distribution

U.S. Nationwide distribution including in the states of CA, DC, FL, GA, MD, MN, MT, VA, and WA. O.U.S.: None

## Key facts

- **Recall number:** Z-0847-2021
- **Recalling firm:** VISBY MEDICAL INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-05
- **Report date:** 2021-01-20
- **Termination date:** 2022-01-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0847-2021

## Citation

> AI Analytics. FDA recall Z-0847-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0847-2021. Source: US FDA. Licensed CC0.

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