Class 2 Device Recall YEASTONE BROTH

• Date Initiated by Firm: March 24, 2026
• Date Posted: April 10, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1806-2026
• Recall Event ID: 98616
• 510(K)Number: K090968
• Product Classification: Susceptibility test plate, antifungal - Product Code NGZ
• Product: Yeastone Broth, 11ML, 10/BOX YY3462
• Code Information: UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723
• FEI Number: 1924669
• Recalling Firm/ Manufacturer: Remel, Inc; 12076 Santa Fe Trail Dr; Lenexa KS 66215-3519
• For Additional Information Contact: Erica Knox; 800-255-6730
• Manufacturer 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: 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.
• Quantity in Commerce: 2819
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NGZ