LYFO DISK recallZ-0308-2024 · Microbiologics Inc · initiated Oct 18, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Microbiologics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-0308-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 18, 2023
- Posted by the FDA
- Nov 15, 2023
- Recalling firm
- Microbiologics Inc
- Quantity
- 3 units
- Product code
- JTR
- FDA submissions
- K861022
- Distribution
- Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.
Product description
LYFO-DISK, P. venetum, Catalog number 0794L
Code information (models, lots, serial numbers)
UDI/DI 10845357019186, Lot Numbers: 794-142-1
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LYFO DISK™ 0794LMicrobiologics Inc. · KIT, QUALITY CONTROL FOR CULTURE MEDIA1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93267).
- Z-0307-2024 · Open, ClassifiedKWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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