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.
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.
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.
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.
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.
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.
Look for the lot number on the outer box of the test kit to determine if it's one of the affected lots.
The recall is due to two issues: some lots have incorrect labeling claiming CLIA Waived status, and some lots contain components that expire before the kit's expiration date.
Check the lot number on the outer box. If it's one of the affected lots, contact Visby Medical for instructions.
The test kits are safe to use if they are not affected lots, but the recalled lots may lead to inaccurate results or ineffective tests.
We’ve drafted a message you can send Visby Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0847-2021 — Visby Medical Visby Medical Hello, I own a Visby Medical that is covered by recall Z-0847-2021 from Visby Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
