Medical device recalls

Microbiologics Inc recalls LYFO Disk

Recall date
July 17, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0788-2022
FDA classification
Class III
Brand / firm
Microbiologics Inc
Sold / distributed
Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

LYFO Disk

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