RegWardenFDA facility compliance records
Company

ADVANCED INSTRUMENTS, LLC

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

Recalls by year

FDA actions on record by year2018: 1 recalls; 2024: 1 recalls201712018201920202021202220231202420252026
  • Recalls (2)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2024-03-11
    System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.
  • Class IITerminated2018-02-07
    RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, preventing user from testing patient samples for RBC.

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. “ADVANCED INSTRUMENTS, LLC — 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-1217058-advanced-instruments-llc/

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