LYFO-DISK, P. venetum, Catalog number 0794L
FDA device recall Z-0308-2024 · posted 2023-11-15 · Open, Classified
Recall details
- Recalling firm
- Microbiologics Inc
- Reason for recall
- A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JTR
- Quantity affected
- 3 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.
- Date initiated
- 2023-10-18
- Date posted
- 2023-11-15
- Location
- Saint Cloud, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (K861022) | Micro-Bio-Logics | 1986-04-04 |