Visby Medical COVID-19 Test Kit Recall: Incorrect Labeling and Early Expiry
Visby Medical recalls specific lots of their COVID-19 test kits due to incorrect labeling claiming CLIA Waived status and expired components. Consumers should check their lot numbers and contact the company for details.
Lower-risk 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.
Contact the company
What happened, in plain English
Visby Medical is recalling certain lots of their COVID-19 test kits because some have incorrect labeling about being CLIA Waived and others have components that expire before the kit's date. This could lead to inaccurate test results or ineffective tests if used. Read more at govinfonow.com/recall/63723-visby-medical-covid-19-test-kit-recall-incorrect-labeling-and.
Source Summary by GovInfoNow · govinfonow.com/recall/63723-visby-medical-covid-19-test-kit-recall-incorrect-labeling-and · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0847-2021
Cite this page
“Visby Medical COVID-19 Test Kit Recall: Incorrect Labeling and Early Expiry.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63723-visby-medical-covid-19-test-kit-recall-incorrect-labeling-and. Based on FDA recall #Z-0847-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0847-2021%22&limit=1).
Why it’s dangerous
The test kits have two issues: some lots incorrectly label the product as CLIA Waived (meaning they don't need FDA approval), which could lead to improper use, and some lots have components that expire before the kit's expiration date, making the test ineffective.
Who’s affected
People who purchased the Visby Medical COVID-19 test kits with lot numbers LN20100067, LN20100148, LN20110040, LN20110213, or WR20100003 are affected. Those using the kits for home testing may be at risk of inaccurate results.
How to tell if you have this one
Check the lot number on the outer box of the test kit. Affected lots include LN20100067, LN20100148, LN20110040, LN20110213, and WR20100003. The product was sold under FDA Emergency Use Authorization.
- Brand
Visby Medical- Category
Medical device
What to do — step by step
Check Lot Number
Look for the lot number on the outer box of the test kit to determine if it's one of the affected lots.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
FDA distribution: “U.S. Nationwide distribution including in the states of CA, DC, FL, GA, MD, MN, MT, VA, and WA. O.U.S.: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, District of Columbia, Florida, Georgia, Maryland, Minnesota, Montana, Virginia, Washington.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0847-2021 (December 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0847-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.