RegWardenFDA facility compliance records
Company

STANBIO LABORATORY

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

Recalls by year

FDA actions on record by year2018: 2 recalls; 2021: 1 recalls; 2022: 1 recalls; 2023: 1 recalls20172201820192020120211202212023202420252026
  • Recalls (5)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2023-10-02
    Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coatin…
  • Class IITerminated2022-03-16
    The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)
  • Class IIITerminated2021-07-12
    Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
  • Class IITerminated2018-02-13
    All patient serum samples yield a weakly positive test result.
  • Class IITerminated2018-02-08
    The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.

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. “STANBIO LABORATORY — 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-1616487-stanbio-laboratory/

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