Facility

Exact Sciences Corporation- Legacy Campus

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

Key facts

1recalls · worst Class II

2inspections · worst NAI

—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)	3013841562
Establishment type	Manufacture Medical Device
Location	320 Holtzman Road Madison, WI, US 53713
Registration status	Active · expires 2026
Parent company	Exact Sciences Corporation (owner-operator 10047364)
Brand names	Sample Mixer; Sample Mixer 2

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Blender/Mixer
Product code JRO (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2050

Recalls & enforcement

Class IITerminated2017-04-28
Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens during a run and the Sample Holder lid makes contact with the Sample Mixer door.

FDA inspections (2)

NAI2024-06-25
No Action Indicated · Compliance: Devices
NAI2019-07-30
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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. “Exact Sciences Corporation- Legacy Campus (FEI 3013841562) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013841562-exact-sciences-corporation-legacy-campus/

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