Recall StatusOpen, Classified
Date Initiated2026-03-24
Product Quantity2819
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.
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 investigating the root cause and will implement corrective and preventive actions to prevent future recurrence.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.