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Microbiologics Inc recalls LYFO Disk

Recalled March 23, 2022 · FDA recall Z-0788-2022 · Microbiologics

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. · FDA Class III
Units
3 units
Sold at
Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.

Description

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.

Product
LYFO Disk
Manufacturer(s)
Microbiologics Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Microbiologics Inc recalls LYFO Disk | RecallWatchUSA