FDA Medical Device Recalls (openFDA)
Microbiologics Inc: LYFO-DISK, P. venetum, Catalog number 0794L
- Recall number
- Z-0308-2024
- Recalling firm
- Microbiologics Inc
- Product
- LYFO-DISK, P. venetum, Catalog number 0794L
- Status
- Open, Classified
- Initiated
- 2023-10-18
- Posted
- 2023-11-15
- Terminated
- not on file
- Reason
- A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
- Root cause
- Under Investigation by firm
- Action
- Microbiologics issued an Urgent Medical Device Recall notice to its consignees on 10/18/2023 via email. The notice explained the issue and requested that the labs review their procedures to understand who the issue affects its usage, use or discard depending on its procedures, and contact Microbiologics if a replacement kit is needed. For questions or concerns contact the Recall Support team at 1.320.229.7073 or recall@microbiologics.com.
- Quantity
- 3 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.
- Lot, serial or model codes
- UDI/DI 10845357019186, Lot Numbers: 794-142-1
- 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