Diasol Acid Concentrate REF G100325-10Dex 100
FDA device recall Z-0207-2025 · posted 2024-10-23 · Open, Classified
Recall details
- Recalling firm
- Diasol, Inc
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Open, Classified
- Product code
- KPO
- Quantity affected
- 852 gallon bottles
- Distribution
- U.S. Nationwide distribution in the state of AZ.
- Date initiated
- 2022-07-27
- Date posted
- 2024-10-23
- Location
- Phoenix, AZ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMODIALYSIS CONCENTRATE ADDITIVES (K851431) | Dana Laboratories | 1985-06-12 |