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U.S. Department of Health and Human Services

Class 2 Device Recall Microbiologics KWIKSTIK

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  Class 2 Device Recall Microbiologics KWIKSTIK see related information
Date Initiated by Firm October 18, 2023
Date Posted November 15, 2023
Recall Status1 Open3, Classified
Recall Number Z-0307-2024
Recall Event ID 93267
510(K)Number K861022  
Product Classification Kit, quality control for culture media - Product Code JTR
Product KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
Code Information a) UDI/DI 20845357019169, Lot Numbers: 794-142-2, 794-142-4 b) UDI/DI 30845357019173, Lot Numbers: 794-142-3
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information Contact Becky Neu
320-229-7073
Manufacturer Reason
for Recall		 A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
FDA Determined
Cause 2		 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 in Commerce 13 units
Distribution Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JTR and Original Applicant = MICRO-BIO-LOGICS
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