FDA recall Z-0788-2022

Product

LYFO Disk

Reason for recall

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.

Distribution

Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.

Key facts

Status

Completed

Initiation date

2015-07-17

Report date

2022-03-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0788-2022