Recall Z-1806-2026— Remel, Inc

Name: FDA recall Z-1806-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-24

Class II · Ongoing

Class II FDA medical device recall by Remel, Inc, initiated 2026-03-24. It names one FDA 510(k) clearance: K090968. Product: Yeastone Broth, 11ML, 10/BOX YY3462. Reason: 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..

Recalling firm: Remel, Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-03-24
Firm location: Lenexa, KS, United States

510(k) clearances named in this recall

1 on FDA's record

K090968 — SENSITITRE YEASTONE SUSCEPTIBILITY PLATESTrek Diagnostic Systems, Inc.·cleared 2009-06-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Yeastone Broth, 11ML, 10/BOX YY3462

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.