SD Biosensor recalls STANDARD Q COVID-19 Ag Home Test kits imported illegally into the U.S. that aren't approved for distribution. These tests may not be safe or effective.
Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.
SD Biosensor is recalling STANDARD Q COVID- 19 Ag Home Test kits that were illegally imported into the U.S. These tests aren't approved for use in the U.S. and could be unsafe or ineffective.
The tests were imported illegally into the U.S. without proper approval. This means they may not be safe or effective for use in the U.S. as they weren't tested or approved by the FDA.
Anyone who owns or uses these kits. People who use them for testing may be at risk of receiving inaccurate results or using unapproved products.
Check for the lot number 59628J1T1 (or 59628J1T1/2) on the packaging. These kits were sold through illegal imports and are not approved by the U.S. government.
Look for the lot number 59628J1T1 (or 59628J1T1/2) on the packaging to confirm if it's recalled.
The official notice states these tests are not approved for distribution in the U.S., so they may not be safe or effective.
Check for the lot number 59628J1T1 (or 59628J1T1/2) on the packaging. These kits were illegally imported and not approved by the U.S. government.
The recall record doesn't specify a remedy, so you should check with the manufacturer or contact the FDA for guidance.
We’ve drafted a message you can send SD Biosensor to request your refund or repair — edit it as you like.
Subject: Recall Z-0719-2022 — SD Biosensor SD Biosensor Hello, I own a SD Biosensor that is covered by recall Z-0719-2022 from SD Biosensor. 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.
