Facility

Advance Dx, Inc.

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)	3006457763
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Repack or Relabel Medical Device
Location	11250 North 118th Way Scottsdale, AZ, US 85259
Registration status	Active · expires 2026
Parent company	Advance Dx, Inc. (owner-operator 9106741)
Brand names	ADVANCEDX 100 SERUM SEPARATOR

Activity by year

Recalls (1)

Devices registered here (1)

Container, Specimen Mailer And Storage, Non-Sterile
Product code NNK (opens in a new tab) · Class I · Pathology · 21 CFR 864.3250

Recalls & enforcement

Class IITerminated2021-07-06
Due to high glucose test results when using the blood collection cards.

All facilities operated by Advance Dx, Inc.

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. “Advance Dx, Inc. (FEI 3006457763) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006457763-advance-dx-inc/

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