Z-0355-2027

Yeastone Broth, 11ML, 10/BOX, used in antibiotic susceptibility testing of mycological clinical specimens

Name: Z-0355-2027 Yeastone Broth, 11ML, 10/BOX, used in antibiotic susceptibility testing of mycological clinical specimens
Creator: Remel, Inc
Published: 2026-10-19
License: https://open.fda.gov/license/

Remel, Inc / initiated 2026-10-19 / Open, Classified

FDA source

Recall record

Recall number: Z-0355-2027
Status: Open, Classified
Initiated: 2026-10-19
Posted: 2026-11-03
Recalling firm: Remel, Inc
Product: Yeastone Broth, 11ML, 10/BOX, used in antibiotic susceptibility testing of mycological clinical specimens
Product code: NGZ Susceptibility Test Plate, Antifungal
Reason for recall: Affected lot did not meet specifications. Product may report false susceptibility to antifungal agents, specifically within the Azole family.
FDA root cause: Under Investigation by firm
Action: The firm began notifying affected customers on October 19, 2026. Customers were instructed to notify any personnel who needed to be aware of the issue. Customers should review previously reported susceptibility results generated using the affected lot and assess whether retesting is appropriate. Customers should destroy any remaining inventory of the affected lot. Do not use it for any clinical laboratory testing. Customers should complete and return the acknowledgement form accompanying the letter. Firm will replace product or issue credit. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email [email protected]. You should complete the accompanying Acknowledgment Form upon receipt and return to [email protected]
Quantity in commerce: 33 US, 54 OUS
Distribution: Worldwide - US Nationwide distribution in the states of MA and CA. The countries of India, Saudi Arabia, UK.
Product codes and lots: YY3462 lot 440400 UDI-DI 848838018817

Product code NGZ

K090968Class IISensititre Yeastone Susceptibility PlatesTrek Diagnostic Systems, Inc. / cleared 2009-06-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-28, the FDA export date for this dataset. Page last changed 2026-11-06. View this recall on fda.gov (opens on fda.gov)