RegWardenFDA facility compliance records
Company

SD Biosensor, Inc.

2 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2022: 1 recalls; 2023: 1 recalls201720182019202020211202212023202420252026
  • Recalls (2)

Registered facilities (2)

Recalls & enforcement

  • Class IOngoing2023-03-31
    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.
  • Class IOngoing2022-01-31
    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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “SD Biosensor, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10035779-sd-biosensor-inc/

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