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

• Date Initiated by Firm: August 14, 2023
• Date Posted: September 11, 2023
• Recall Status: Open, 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: 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