PlainRecalls
FDA Devices Low Class III Completed

LYFO Disk

Reported: March 23, 2022 Initiated: July 17, 2015 #Z-0788-2022

Product Description

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.

Details

Recalling Firm
Microbiologics Inc
Units Affected
3 units
Distribution
Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.
Location
Saint Cloud, MN

Frequently Asked Questions

What product was recalled?
LYFO Disk. Recalled by Microbiologics Inc. Units affected: 3 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 23, 2022. Severity: Low. Recall number: Z-0788-2022.