Recall Atlas

SD Biosensor recalls

2 official recalls and safety alerts involving SD Biosensor since 2022-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with SD Biosensor or the relevant agency.

  1. 2023-05-31
  2. US
    Drugs & medicalClass I

    SD Biosensor, Inc. recalls Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)

    The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.

    FDA · DeviceSD Biosensor, Inc.US Nationwide.Official notice →
  3. 2022-03-23
  4. US
    Drugs & medicalClass I

    SD Biosensor, Inc. recalls STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of…

    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.

    FDA · DeviceSD Biosensor, Inc.U.S. Nationwide DistributionOfficial notice →