Facility

Clarity Diagnostics, LLC

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

Key facts

1recalls · worst Class III

2inspections · 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)	3004043187
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	1701 Green Rd Ste A Deerfield Bch, FL, US 33064
Registration status	Active · expires 2026
Parent company	Clarity Diagnostics (owner-operator 9057600)
Brand names	Clarity Urine Pregnancy Tests

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Visual, Pregnancy Hcg, Prescription Use
Product code JHI (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1155

Recalls & enforcement

Class IIITerminated2018-06-22
Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of Canister Code Bar Code Label.

FDA inspections (2)

NAI2022-04-06
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2019-05-08
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 Clarity Diagnostics

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. “Clarity Diagnostics, LLC (FEI 3004043187) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004043187-clarity-diagnostics-llc/

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