DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICA... (Diasol, Inc) – incorrect labeling of dialysate conce... (2020)
Incorrect dialysate concentration labeling can potentially impact treatment accuracy.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Brand
Diasol, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Model Number: 100225-10-DEX100 Gallons Unique Device Identifier (UDI): B467100225101004 and B4671000225101004 Lot codes if applicable: PHQ03041/030920
Diasol, Inc is recalling DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS due to Incorrect labeling of dialysate concentration for hemodialysis.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect labeling of dialysate concentration for hemodialysis.
Recommended Action
Per FDA guidance
On 04/30/2020, the firm called customers informing them of the labeling error and instructed customers to: -Check if they have any remaining stock -Discontinue use of the specific lot -See if there have been any adverse events if used On 05/01/2020 the firm sent an "URGENT: MEDICAL DEVICE RECALL" to customers via certified mail informing them of the above and to contact customer service at (602) 442-7670 to arrange pickup of any stock of this lot number and replacement of a different lot number will be provided. For questions, contact Customer Service at (602) 442-7670.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA
Page updated: Jan 10, 2026