Recall Z-1806-2026

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.

FDA-determined cause: Under Investigation by firm

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.