Recall Z-0307-2024 ยท JTR Kit, Quality Control For Culture Media
Microbiologics Inc
KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
| Date | Nov 15, 2023 (initiated Oct 18, 2023) |
| Status | Open, Classified |
| 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 | 13 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K861022 | KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS Micro-Bio-Logics, Apr 4, 1986 |