Facility

Advanced Instruments, LLC

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

Key facts

2recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1217058
Establishment type	Manufacture Medical Device
Location	2 Technology Way NORWOOD, MA, US 02062
Registration status	Active · expires 2026
Parent company	ADVANCED INSTRUMENTS, LLC (owner-operator 1217058)
Brand names	Bilirubin Stat-Analyzer

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Diazo Colorimetry, Bilirubin
Product code CIG (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1110

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.

FDA inspections (1)

VAI2017-08-04
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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. “Advanced Instruments, LLC (FEI 1217058) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1217058-advanced-instruments-llc/

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