—#219240

Product

Yeastone Broth, 11ML, 10/BOX YY3462

FDA product code: NGZ — Susceptibility Test Plate, Antifungal
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K090968
Affected lot / code info: UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Remel, Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.

Timeline

Recall initiated: 2026-03-24
Posted by FDA: 2026-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #219240. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.