Device recall

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

FDA recall source

Recall number

Z-0355-2027

Event id

100139

Status

Open, Classified

FDA classification

Class II

Recalling firm

Remel, Inc

Posted

Nov 3, 2026

Initiated

Oct 19, 2026

Product code

NGZ

Device type

Susceptibility Test Plate, Antifungal

Reason

Affected lot did not meet specifications. Product may report false susceptibility to antifungal agents, specifically within the Azole family.

Root cause

Under Investigation by firm

Quantity

33 US, 54 OUS

Code info

YY3462 lot 440400 UDI-DI 848838018817

Distribution

Worldwide - US Nationwide distribution in the states of MA and CA. The countries of India, Saudi Arabia, UK.

Related 510(k)s

K090968

Location

Lenexa, KS