← FDA ENFORCEMENT
Z-0992-2026Class II
Diasol, Inc
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Diasol, Inc
Product type
Device
Status
Ongoing
Report date
2025-12-31
Distribution
US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
Firm state
AZ
Product quantity
2200 gallons
Initiated by
Voluntary: Firm initiated
Reason for recall
Safety and efficacy of dialysis acid concentrate cannot be assured
Product description
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Code / lot info
UDI: None/Lot Code: PHV08042
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →