Yeastone Broth, 11ML, 10/BOX YY3462
FDA device recall Z-1806-2026 · posted 2026-04-10 · Open, Classified
Recall details
- Recalling firm
- Remel, Inc
- 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.
- Action taken
- Firm began notifying consignees on March 24, 2026 via letters titled "Urgent: Medical Device Recall." Customers were informed that the affected products may report incorrect AST results during quality control. Customers were asked to notify any personnel who need to be aware of the issue. Laboratory professionals are advised to review previously reported susceptibility results generated using affected lots and assess whether retesting is appropriate. Remaining inventory of affected lots must be destroyed; these lots should not be used for any clinical laboratory testing. The firm is investigating the root cause and will implement corrective and preventive actions to prevent future recurrence.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NGZ
- Quantity affected
- 2819
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.
- Date initiated
- 2026-03-24
- Date posted
- 2026-04-10
- Location
- Lenexa, KS
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SENSITITRE YEASTONE SUSCEPTIBILITY PLATES (K090968) | Trek Diagnostic Systems, Inc. | 2009-06-04 |