RegWardenFDA facility compliance records
Facility

SD BIOSENSOR, INC.

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

Activity by year

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

Devices registered here (2)

  • System, Test, Blood Glucose, Over The Counter
    Product code NBW (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345
  • Glucose Oxidase, Glucose
    Product code CGA (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345

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.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SD BIOSENSOR, INC. (FEI 3012133212) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012133212-sd-biosensor-inc/

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