Diasol Acid Concentrate Recalled for Labeling Discrepancy
Diasol, Inc. is recalling 852 gallon bottles of Diasol Acid Concentrate because the gallon label shows a lower calcium concentration than the box label.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling discrepancy without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Diasol, Inc. is recalling 852 gallon bottles of Diasol Acid Concentrate (REF G100325-10Dex 100) due to a labeling issue. The recall affects products with Catalog Number G100325-10Dex100, UDI code B467100325101004, and Lot Number PHS06011/061722.
The recall was initiated because the box label and the gallon label display different calcium concentrations. Specifically, the gallon label shows a lower calcium concentration than the box label. The product was distributed nationwide in the state of Arizona.
Consumers and healthcare facilities should check their inventory for the specific lot number and contact Diasol, Inc. for instructions on how to return the product.
The recalled product
- Product
- Diasol Acid Concentrate REF G100325-10Dex 100
- Manufacturer
- Diasol, Inc
- Category
- Medical Device — Dialysis Fluid
- Hazard
Distribution
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