Visby Medical Recalls 282 COVID-19 Test Kits for Labeling Errors
Visby Medical is recalling 282 COVID-19 test kits because some boxes incorrectly state the product is CLIA Waived and some components expire before the kit expiration date.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazards involve labeling errors and component expiration dates, which are administrative and quality control issues rather than direct physical or biological hazards causing immediate harm, fitting the criteria for moderate severity.
Plain-English summary
Visby Medical Inc. is recalling 282 units of the Visby Medical COVID-19 Test kit. This in vitro diagnostic is used for the qualitative detection of SARS-CoV-2 and is intended for use only under the Food and Drug Administration’s Emergency Use Authorization.
The recall addresses two specific issues. First, five lots were found to have incorrect labeling on the outer box, stating that the product is CLIA Waived. Second, three lots contain a kit component that expires prior to the expiration date listed on the test kits. The affected lots are LN20100067, LN20100148, LN20110040, LN20110213, and WR20100003, with Part Number PS-001442.
The products were distributed nationwide in the United States, including in California, the District of Columbia, Florida, Georgia, Maryland, Minnesota, Montana, Virginia, and Washington. No distribution outside the U.S. is reported. Users should stop using the affected kits and contact Visby Medical for further instructions.
The recalled product
- 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.
- Manufacturer
- VISBY MEDICAL INC
- Affected units
- 282
Distribution
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