Class 3 Device Recall MAS Omni Immune PRO Controls

• Date Initiated by Firm: December 02, 2013
• Date Posted: June 26, 2014
• Recall Status: Terminated on July 08, 2014
• Recall Number: Z-1930-2014
• Recall Event ID: 67011
• 510(K)Number: K110616
• Product Classification: Multi-analyte controls, all kinds (assayed) - Product Code JJY
• Product: MAS Omni Immune PRO Controls
• Code Information: Part Number Lot number OPR0-101 OPR015101 OPR0-202 OPR015102 OPR0-303 OPR015103 OPRO-SP OPR01510S All lots have an expiration date of 10/31/2015.
• Recalling Firm/ Manufacturer: Microgenics Corporation; 44660 Osgood Rd; Fremont CA 94539-6410
• For Additional Information Contact: Mark Smith; 510-979-5000
• Manufacturer Reason for Recall: The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change.
• FDA Determined Cause: Labeling Change Control
• Action: Urgent Medical Device Correction letters were sent on December 2, 2013 to all affected customers and distributors via trackable mail.
• Quantity in Commerce: 1393
• Distribution: Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.
• 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.

• 510(K) Database: 510(K)s with Product Code = JJY