Z-1806-2026Class II

Yeastone Broth, 11ML, 10/BOX YY3462

Name: Z-1806-2026 Yeastone Broth, 11ML, 10/BOX YY3462
Creator: Remel, Inc
Published: 2026-03-24
License: https://open.fda.gov/license/

Remel Inc / initiated 2026-03-24 / Open, Classified

FDA source

Remel, Inc began a recall of Yeastone Broth, 11ML, 10/BOX YY3462 on 2026-03-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1806-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-24
Posted: 2026-04-10
Recalling firm: Remel Inc
Product: Yeastone Broth, 11ML, 10/BOX YY3462
Product code: NGZ Susceptibility Test Plate, Antifungal
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 root 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.
Product codes and lots: UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1806-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1806-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-10

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)