Facility

ALCOR SCIENTIFIC LLC

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

Key facts

1recalls · 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)	3003855297
Establishment type	Manufacture Medical Device
Location	20 Thurber Blvd Smithfield, RI, US 02917
Registration status	Active · expires 2026
Parent company	ALCOR Scientific LLC (owner-operator 10027445)
Brand names	iSED; miniiSED; iSED Elite; iSEDPro

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Device, Automated Sedimentation Rate
Product code GKB (opens in a new tab) · Class I · Hematology · 21 CFR 864.5800

Recalls & enforcement

Class IIOngoing2022-07-20
Primary Pump Tubing Spare Part is incorrect. If the tubing is installed onto an ALCOR iSED ESR Analyzer, there is a potential of a biohazard leak from the iSEDs Probe Tube

FDA inspections (1)

VAI2018-12-18
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.

All facilities operated by ALCOR Scientific LLC

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. “ALCOR SCIENTIFIC LLC (FEI 3003855297) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003855297-alcor-scientific-llc/

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