Recall Z-1930-2014— Microgenics Corporation

Name: FDA recall Z-1930-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-02

Class III · Terminated

Class III FDA medical device recall by Microgenics Corporation, initiated 2013-12-02, terminated 2014-07-08. It names one FDA 510(k) clearance: K110616. Product: MAS Omni Immune PRO Controls. Reason: 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..

Recalling firm: Microgenics Corporation
Classification: Class III
Status: Terminated
Initiated: 2013-12-02
Terminated: 2014-07-08
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K110616 — THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROMicrogenics Corp.·cleared 2011-06-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MAS Omni Immune PRO Controls

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.