Yeastone Broth, 11ML, 10/BOX recallZ-1806-2026 · Remel, Inc · initiated Mar 24, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remel, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1806-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 24, 2026
- Posted by the FDA
- Apr 10, 2026
- Recalling firm
- Remel, Inc
- Quantity
- 2819
- Product code
- NGZ
- FDA submissions
- K090968
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.
Product description
Yeastone Broth, 11ML, 10/BOX YY3462
Code information (models, lots, serial numbers)
UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA Y3462Remel, Inc. · Susceptibility Test Plate, Antifungal1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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