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U.S. Department of Health and Human Services

Class 3 Device Recall MAS Omni Immune Controls

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  Class 3 Device Recall MAS Omni Immune Controls see related information
Date Initiated by Firm December 02, 2013
Date Posted June 26, 2014
Recall Status1 Terminated 3 on July 08, 2014
Recall Number Z-1929-2014
Recall Event ID 67011
510(K)Number K110616  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product MAS Omni Immune Controls
Code Information Part Number Lot number OIM-101 OIM15091 OIM-202 OIM15092 OIM-303 OIM15093 OIM-SP OIM1509S. All lots have an expiration date of 9/30/2015.
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 2		 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 3185
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 and Original Applicant = MICROGENICS CORP.
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