Facility

DIASOL INC

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

Key facts

3recalls · worst Class II

5inspections · worst OAI

2warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3007137482
Establishment type	Manufacture Medical Device
Location	310 S 43RD AVE Phoenix, AZ, US 85009
Registration status	Active · expires 2026
Parent company	DIASOL, INC. (owner-operator 9035798)
Brand names	DIASOL BICARB

Activity by year

Recalls (3)
Inspections (5)
Warning letters (2)

Devices registered here (1)

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Product code KPO (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5820

Recalls & enforcement

Class IIOngoing2025-11-05
Safety and efficacy of dialysis acid concentrate cannot be assured
Class IIOngoing2022-07-27
Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label.
Class IITerminated2020-04-30
Incorrect labeling of dialysate concentration for hemodialysis.

FDA inspections (5)

OAI2025-08-19
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2024-02-28
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2021-06-28
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
OAI2017-06-21
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2017-02-08
No Action Indicated · Compliance: 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.

FDA warning letters (2)

Warning Letter2026-01-30
Warning Letter (opens in a new tab) · Phoenix Arizona
Warning Letter2017-09-25
Warning Letter (opens in a new tab) · Phoenix Arizona

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by DIASOL, 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. “DIASOL INC (FEI 3007137482) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007137482-diasol-inc/

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