Quidel recalls a specific lot of Sofia 2 Flu + SARS Antigen FIA tests with incorrect expiration dates. The kits may expire before the actual shelf life, potentially leading to inaccurate results. Affected units have lot number 709083.
One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct expiration date for the pouches is September 12, 2024. The kits are labeled with an expiration date of April 30, 2025, however, the correct expiration date for the kits is September 12, 2024. The issue was discovered on November 28, 2023 by a supply chain employee who determined that the kits had expiration dates beyond the FDA authorized shelf life.
Quidel is recalling a specific lot (709083) of Sofia 2 Flu + SARS Antigen FIA tests because they were labeled with incorrect expiration dates. Using these tests after the wrong expiration date could lead to inaccurate results, which might affect test reliability.
The test kits were labeled with expiration dates that are later than the actual shelf life. This means the tests could become inaccurate before the stated expiration date, potentially leading to false negative or positive results.
People who purchased the Sofia 2 Flu + SARS Antigen FIA test kit with lot number 709083 are affected. Those using the test for home use are most at risk of getting inaccurate results.
Check for the lot number 709083 on the test kit packaging. The kits were sold with incorrect expiration dates of May 31, 2025 and April 30, 2025, but the correct expiration date is September 12, 2024.
Verify the expiration date on the test kit packaging. If it shows May 31, 2025 or April 30, 2025, it is part of the recalled lot.
The lot number 709083 was labeled with incorrect expiration dates that are later than the actual shelf life, which could lead to inaccurate test results.
The official recall notice does not specify a remedy for this lot, so you should check the expiration date and avoid using the test if it has expired.
The test is safe to use as long as it is used before the correct expiration date of September 12, 2024. Using it after this date could lead to inaccurate results.
We’ve drafted a message you can send Quidel to request your refund or repair — edit it as you like.
Subject: Recall Z-1086-2024 — Quidel Quidel Hello, I own a Quidel that is covered by recall Z-1086-2024 from Quidel. 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.
