Recall Z-0355-2027 ยท NGZ Susceptibility Test Plate, Antifungal
Remel, Inc
Yeastone Broth, 11ML, 10/BOX, used in antibiotic susceptibility testing of mycological clinical specimens
| Date | Nov 3, 2026 (initiated Oct 19, 2026) |
| Status | Open, Classified |
| Reason | Affected lot did not meet specifications. Product may report false susceptibility to antifungal agents, specifically within the Azole family. |
| Root cause | Under Investigation by firm |
| Action | The firm began notifying affected customers on October 19, 2026. Customers were instructed to notify any personnel who needed to be aware of the issue. Customers should review previously reported susceptibility results generated using the affected lot and assess whether retesting is appropriate. Customers should destroy any remaining inventory of the affected lot. Do not use it for any clinical laboratory testing. Customers should complete and return the acknowledgement form accompanying the letter. Firm will replace product or issue credit. If you have any questions, please contact our |
| Quantity | 33 US, 54 OUS |
| Distribution | Worldwide - US Nationwide distribution in the states of MA and CA. The countries of India, Saudi Arabia, UK. |
| 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 |