FDA Medical Device Recalls (openFDA)
Microbiologics Inc: LYFO Disk
- Recall number
- Z-0788-2022
- Recalling firm
- Microbiologics Inc
- Product
- LYFO Disk
- Status
- Completed
- Initiated
- 2015-07-17
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Labeling mix-ups
- Action
- Microbiologics notified customers on 07/17/2015 via letter titled "Medical Device Recall". Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall (LYFO DISK 0983L, Lot# 983-40-3), it is recommended that the customer destroys the product or return it to the recalling firm. Acknowledgement of the receipt of the recall letter was requested by completing a form and returning to Microbiologics. Questions or concerns can be directed to the Quality Systems Manager at 320.229.7050.
- Quantity
- 3 units
- Distribution
- Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.
- Lot, serial or model codes
- Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)
- 510(k) numbers
- ["K861022"]
- PMA numbers
- not on file
- Product code
- JTR
- Firm FEI
- 2150138
- Firm city
- Saint Cloud
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28