FDA DevicesClass II
Yeastone Broth, 11ML, 10/BOX YY3462
Published: April 22, 2026Recall ID: Z-1806-2026Category: devicesCountry: US
Reason for Recall / Hazard
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
Product Description & Identification
Yeastone Broth, 11ML, 10/BOX YY3462
Affected Products
Yeastone Broth, 11ML, 10/BOX YY3462
Additional Source Details
| Field | Value |
|---|---|
| City | Lenexa |
| State | KS |
| Event id | 98616 |
| Address 1 | 12076 Santa Fe Trail Dr |
| Address 2 | N/A |
| Code info | UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723 |
| Postal code | 66215-3519 |
| Report date | 20260422 |
| Product type | Devices |
| Product quantity | 2819 |
| Reason for recall | Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260324 |
| Initial firm notification | Letter |
| Center classification date | 20260410 |
Overview
- Recalling FirmRemel, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.