Class 2 Device Recall Helix Elite Molecular Standards

• Date Initiated by Firm: March 22, 2022
• Create Date: April 19, 2022
• Recall Status: Terminated on January 09, 2023
• Recall Number: Z-0955-2022
• Recall Event ID: 89887
• Product Classification: Multi-analyte controls unassayed - Product Code OHQ
• Product: Inactivated macrolide-resistant Mycoplasma genitalium
• Code Information: Catalog # HE0070N; Lot HE0070-01-1 UDI: 10845357044003
• FEI Number: 2150138
• Recalling Firm/ Manufacturer: Microbiologics Inc; 200 Cooper Ave N; Saint Cloud MN 56303-4440
• For Additional Information Contact: Becky Neu; 320-253-1640
• Manufacturer Reason for Recall: The QC process was not adequate for the specification range.
• FDA Determined Cause: Process control
• Action: A customer letter, dated 03/24/2022, was issued to the impacted consignee via email. The consignee is instructed to destroy the product as it is now past its updated expiration date. The consignee is asked to complete the response form and submit to the recalling firm.
• Quantity in Commerce: 2 ea
• Distribution: US Nationwide distribution in the states of NV and VT.
• 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.