Recall Z-0308-2024
Microbiologics Inc · initiated October 18, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LYFO-DISK, P. venetum, Catalog number 0794L
Codes / lots: UDI/DI 10845357019186, Lot Numbers: 794-142-1
Reason for recall
A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0308-2024
- Initiated
- October 18, 2023
- Posted by FDA
- November 15, 2023
- Product code
- JTR – Kit, Quality Control For Culture Media
- Quantity
- 3 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0307-2024 Class II | KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus… | 10/18/2023Open, Classified |