FDAClass IIIMarch 23, 2022

LYFO Disk recall: Labeling Error

LYFO Disk

Why was LYFO Disk 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)

Product
LYFO Disk
Recalling firm
Microbiologics Inc
Quantity
3 units
Distribution
Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.
Recall date
March 23, 2022
Classification
Class III
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls