Recall Z-1930-2014 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Microgenics Corporation
MAS Omni Immune PRO Controls
| Date | Jun 26, 2014 (initiated Dec 2, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Labeling Change Control |
| Action | Urgent Medical Device Correction letters were sent on December 2, 2013 to all affected customers and distributors via trackable mail. |
| Quantity | 1393 |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110616 | THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO Microgenics Corp., Jun 29, 2011 |