FDA-Device2022-03-23Class III
LYFO Disk
Microbiologics Inc
Hazard
LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.
Sold states
Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.
Affected count
3 units
Manufactured in
200 Cooper Ave N, N/A, Saint Cloud, MN, United States
Products
LYFO Disk
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0788-2022Don't want to check this manually?
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