Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1930-2014 — MAS Omni Immune PRO Controls

U.S. FDA — Device Enforcement · United States · 2013-12-02 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1930-2014
Date of alert
2013-12-02
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Microgenics Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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