Recall Z-1806-2026 ยท NGZ Susceptibility Test Plate, Antifungal
Remel, Inc
Yeastone Broth, 11ML, 10/BOX YY3462
| Date | Apr 10, 2026 (initiated Mar 24, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 investi |
| Quantity | 2819 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090968 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc., Jun 4, 2009 |