RegWardenFDA facility compliance records
Facility

LetsGetChecked Inc

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2022: 1 recalls20172018201920202021120222023202420252026
  • Recalls (1)

Devices registered here (1)

  • Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
    Product code FMK (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4850

Recalls & enforcement

  • Class IIOngoing2022-03-16
    Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result, a number of users received sample collection kits that were assigned to another user resulting in a mismatch of user identificati…

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. “LetsGetChecked Inc (FEI 3042854290) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3042854290-letsgetchecked-inc/

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