FDA (Devices) recall action 67011
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Microgenics Corporation is recalling MAS Omni Immune PRO Controls because the package insert failed to reflect the removal of the constituent Inhibin A.
Microgenics Corporation is recalling MAS Omni Immune Controls because the package insert failed to reflect the removal of the constituent Inhibin A.