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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 Controlssee related information
Date Initiated by FirmDecember 02, 2013
Date PostedJune 26, 2014
Recall Status1 Terminated 3 on July 08, 2014
Recall NumberZ-1929-2014
Recall Event ID 67011
510(K)NumberK110616 
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
ProductMAS 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 ContactMark 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
ActionUrgent Medical Device Correction letters were sent on December 2, 2013 to all affected customers and distributors via trackable mail.
Quantity in Commerce3185
DistributionWorldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JJY
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