Z-0207-2025Class II

Diasol Acid Concentrate REF G100325-10Dex 100

Name: Z-0207-2025 Diasol Acid Concentrate REF G100325-10Dex 100
Creator: Diasol, Inc
Published: 2022-07-27
License: https://open.fda.gov/license/

Diasol, Inc / initiated 2022-07-27 / Open, Classified / root cause: labeling and UDI

FDA source

Diasol, Inc began a recall of Diasol Acid Concentrate REF G100325-10Dex 100 on 2022-07-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0207-2025
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-27
Posted: 2024-10-23
Recalling firm: Diasol, Inc
Product: Diasol Acid Concentrate REF G100325-10Dex 100
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On 07/26/2022, the firm communicated via email with customer that 2 case were incorrectly labeled. Cases marked 3K 2.5ca have inside box label as 3K 2.0ca. Customer was instructed not to use the product and the firm picked up mislabeled product.
Quantity in commerce: 852 gallon bottles
Distribution: U.S. Nationwide distribution in the state of AZ.
Product codes and lots: Catalog Number: G100325-10Dex100 UDI code: B467100325101004 Lot Number:PHS06011/061722

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0207-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0207-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-23

Product code KPO

K851431Class IIHemodialysis Concentrate AdditivesDana Laboratories / cleared 1985-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)