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U.S. Department of Health and Human Services

Class 3 Device Recall KWIKSTIK, ANA (3 Strains) QC Set

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  Class 3 Device Recall KWIKSTIK, ANA (3 Strains) QC Set see related information
Date Initiated by Firm August 14, 2023
Date Posted September 11, 2023
Recall Status1 Open3, Classified
Recall Number Z-2576-2023
Recall Event ID 92878
510(K)Number K861022  
Product Classification Kit, quality control for culture media - Product Code JTR
Product KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Code Information UDI/DI 70845357025622, Lot Number 5065-26, Exp. 07/31/2024
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		 One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
FDA Determined
Cause 2		 Packaging process control
Action Microbiologics issued an Urgent Medical Device Recall notice to its consignees by email on 08/14/2023. The notice explained the problem with the device and requested the consignee either use or discard the product depending on their lab procedures and how this information affects your usage. Contact Microbiologics if replacement kit is needed.
Quantity in Commerce 4 units
Distribution US Nationwide distribution in the states of MN, PA, TN, TX.
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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