Diasol recalled 186,000 containers of its liquid concentrate for bicarbonate dialysis on November 5, 2025. The company cannot assure the safety and efficacy of the product. Patients and healthcare providers should stop using it immediately and follow recall instructions.
Safety and efficacy of dialysis acid concentrate cannot be assured
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Diasol, Inc or your healthcare provider for instructions. Notification method: E-Mail
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The recall affects the Diasol product with model number 100225-10-DEX100. The product is a liquid concentrate used for bicarbonate dialysis, sold in containers of 208.2 liters. It was distributed nationwide in states including Missouri, California, Arizona, Texas, Illinois, and Massachusetts.
The safety and efficacy of the dialysis acid concentrate cannot be assured. This poses a serious risk to patients relying on the product for dialysis treatment.
Stop using the product immediately. Follow the instructions provided by Diasol and contact your healthcare provider for further guidance. Reach out to Diasol, Inc for additional information.
For more information, contact Diasol, Inc via email. Visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0987-2026 for detailed instructions.
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