Class 2 Device Recall Microbiologics QC Sets and Panels

• Date Initiated by Firm: January 03, 2020
• Create Date: February 05, 2020
• Recall Status: Terminated on September 16, 2020
• Recall Number: Z-1096-2020
• Recall Event ID: 84634
• Product Classification: Multi-analyte controls unassayed - Product Code OHQ
• Product: Vaginal Verification Panel Ref 8208 Lot 8208-11
• Code Information: Lot 8208-11
• FEI Number: 2150138
• Recalling Firm/ Manufacturer: Microbiologics Inc; 200 Cooper Ave N; Saint Cloud MN 56303-4440
• For Additional Information Contact: Kali Sorum, RM(NRCM); 320-229-7064
• Manufacturer Reason for Recall: Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no impact on patient test results as long as Gardnerella vaginalis was properly detected when using Pool 2 and/or users are strictly using this product for instrument verification/validation.
• FDA Determined Cause: Process control
• Action: Letters will be sent via email to all consignees and end users regarding the correction. Users are to review the instructions, determine how the information affects their usage, and upon determination either use with new information or discard the product.
• Quantity in Commerce: 9
• Distribution: Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. No Canada, Mexico or VA.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.