FDA Medical Device Recalls (openFDA)
Diasol, Inc: Diasol Acid Concentrate REF G100325-10Dex 100
- Recall number
- Z-0207-2025
- Recalling firm
- Diasol, Inc
- Product
- Diasol Acid Concentrate REF G100325-10Dex 100
- Status
- Open, Classified
- Initiated
- 2022-07-27
- Posted
- 2024-10-23
- Terminated
- not on file
- Reason
- 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
- 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
- 852 gallon bottles
- Distribution
- U.S. Nationwide distribution in the state of AZ.
- Lot, serial or model codes
- Catalog Number: G100325-10Dex100 UDI code: B467100325101004 Lot Number:PHS06011/061722
- 510(k) numbers
- ["K851431"]
- PMA numbers
- not on file
- Product code
- KPO
- Firm FEI
- 3007137482
- Firm city
- Phoenix
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28