Facility

BIOCARTIS NV

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)	3009972873
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	Generaal De Wittelaan 11B Mechelen Antwerpen, BE 2800
Registration status	Active · expires 2026
Parent company	Biocartis NV (owner-operator 10055159)
Brand names	Idylla MSI Test

Activity by year

Recalls (1)

Devices registered here (1)

Lynch Syndrome Test System
Product code PZJ (opens in a new tab) · Class II · Immunology · 21 CFR 864.1866

Recalls & enforcement

Class IIOngoing2024-12-10
False-positive MSI-H results generated by the Idylla MSI Test.

All facilities operated by Biocartis NV

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. “BIOCARTIS NV (FEI 3009972873) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009972873-biocartis-nv/

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