Facility

INSTITUT GEORGES LOPEZ

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3010765841
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	Parc tertiaire du Bois Dieu Lissieu Auvergne-Rhone-Alpes, FR 69380
Registration status	Active · expires 2026
Parent company	Institut Georges Lopez (owner-operator 10051357)
Brand names	DCX Disposable Cassette; Perfusion Coupler

Activity by year

Recalls (1)

Devices registered here (1)

System, Perfusion, Kidney
Product code KDN (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5880

Recalls & enforcement

Class IIOngoing2025-03-13
The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.

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. “INSTITUT GEORGES LOPEZ (FEI 3010765841) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010765841-institut-georges-lopez/

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