FDAFDA · Food and drugs·Recall number Z-0788-2022
LYFO Disk
Published March 23, 2022 · Recall initiated: July 17, 2015
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Microbiologics Inc
- Distributor
- Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.
- Lot
- Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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