Recall Z-0637-2012 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Microgenics Corporation
ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. Catalog Numbers & Description: CAI-XLL, Level L; CAI-XL1, Level 1; CAI-XL2, Level 2; CAI-XL3, Level 3; CAI-XL4, Multi-Pack; CAI-XLS, Sample Pack;
| Date | Jan 11, 2012 (initiated Dec 14, 2011) |
| Status | Terminated |
| Reason | Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges. |
| Root cause | Nonconforming Material/Component |
| Action | On 12/14/2011, ThermoFisher Scientific issued letters via express mail to all its direct consignees, informing them of the affected products and providing instructions on the recall. |
| Quantity | 25,113 Kits |
| Distribution | Nationwide and Worldwide, including Germany, France, Italy and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061196 | CARDIOIMMUNE XL CARDIAC MARKER CONTROL Microgenics Corp., May 30, 2006 |