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Terminated

MAS Omni Immune PRO Controls

FDA Recall Z-1930-2014 · Posted 2014-06-26

Recalling FirmMicrogenics Corporation
Recall StatusTerminated
Product CodeJJY
Date Initiated2013-12-02
Date Terminated2014-07-08
Product Quantity1393

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.

Firm Action

Urgent Medical Device Correction letters were sent on December 2, 2013 to all affected customers and distributors via trackable mail.

Root Cause

Labeling Change Control

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROMicrogenics Corp. · 2011-06-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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