FDA Recall
Terminated
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;
Recall: Z-0637-2012
·
Initiated December 14, 2011
Recall
- Recall Number
- Z-0637-2012
- Event Number
- 60756
- Firm
- Microgenics Corporation
- FEI Number
- 3010939897
- Product Code
- JJY
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- December 14, 2011
- Posted
- January 11, 2012
- Terminated
- October 26, 2012
- Address
- 44660 Osgood Rd, Fremont, CA, 94539-6410
Description
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;
Reason
Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges.
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.
Distribution
Nationwide and Worldwide, including Germany, France, Italy and Spain.
Quantity
25,113 Kits