Laboratory Culture Disks Recalled for Aspergillus Flavus Contamination
Microbiologics Inc is recalling LYFO-DISK P. venetum laboratory culture disks (lot 794-142) found contaminated with Aspergillus flavus during complaint investigation. The product was distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves contamination with Aspergillus flavus, a pathogenic organism, with no reported illnesses or injuries. The contamination qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Microbiologics Inc is recalling LYFO-DISK, P. venetum laboratory culture disks (Catalog number 0794L). Investigation of a complaint found that bulk pellets in lot 794-142 were contaminated with Aspergillus flavus.
The recalled product was distributed worldwide, including throughout the United States and to the countries of Italy, France, Turkey, Peru, and Mexico. The recall involves lot 794-142-1 (UDI/DI 10845357019186), representing three units of product.
The recalled product
- Product
- LYFO-DISK, P. venetum, Catalog number 0794L
- Manufacturer
- Microbiologics Inc
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 10845357019186
- Lot Numbers: 794-142-1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Microbiologics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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