Class 2 Device Recall Helix Elite

• Date Initiated by Firm: February 25, 2022
• Create Date: March 14, 2022
• Recall Status: Terminated on January 16, 2024
• Recall Number: Z-0784-2022
• Recall Event ID: 89694
• Product Classification: Multi-analyte controls unassayed - Product Code OHQ
• Product: Mycoplasma genitalium Control Panel (Inactivated Pellet)
• Code Information: Catalog 8240, Lots: 8240-08, 8240-09, 8240-10, 8240-11, 8240-12, 8240-13, 8240-14, 8240-15, 8240-16 (UDI: 70845357043053)
• FEI Number: 2150138
• 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: Distributed product did not undergo proper release testing.
• FDA Determined Cause: Nonconforming Material/Component
• Action: All consignees were contacted beginning 02/25/2022 via email. Consignees should read the recall instructions and determine if the product can be used or discarded, depending on user's lab procedures. A response form should be completed and returned to recall@microbiologics.com.
• Quantity in Commerce: 80 units
• Distribution: Distribution in US: AZ, CT, DC, FL, IL, IN, KS, KY, MA, MD, NC, NH, NJ, NY, PA, TX, UT, WA OUS distribution to Belgium, Finland, France, Germany, Ireland, Sweden, United Kingdom, and Vietnam
• 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.