Remel Yeastone Broth recalled for possible false antifungal results
Remel, Inc. is recalling one lot of Yeastone Broth used in antibiotic susceptibility testing of mycological clinical specimens. The affected lot did not meet specifications and may report false susceptibility to Azole-family antifungal agents. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Remel recalls
What to do
- Set aside any Yeastone Broth from lot 440400 (YY3462, UDI-DI 848838018817) and do not use it for susceptibility testing.
- Contact Remel, Inc. for guidance, as the notice does not state a specific remedy.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Yeastone Broth, 11ML, 10/BOX, used in antibiotic susceptibility testing of mycological clinical specimens
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 33 US, 54 OUS
- Illnesses reported
- None reported
- Manufactured in
- 12076 Santa Fe Trail Dr, Lenexa, Kansas, United States
- Classification
- Class II
- Recall number
- Z-0355-2027
In the FDA's words
- Description
- Yeastone Broth, 11ML, 10/BOX, used in antibiotic susceptibility testing of mycological clinical specimens Affected lot did not meet specifications. Product may report false susceptibility to antifungal agents, specifically within the Azole family. 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. Affected quantity: 33 US, 54 OUS
- Hazard
- Affected lot did not meet specifications. Product may report false susceptibility to antifungal agents, specifically within the Azole family.