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;
This recall has been terminated (originally issued January 11, 2012).
- Company
- Microgenics Corporation
- Recall Initiated
- December 14, 2011
- Posted
- January 11, 2012
- Terminated
- October 26, 2012
- Recall Number
- Z-0637-2012
- Quantity
- 25,113 Kits
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges.
Distribution
Nationwide and Worldwide, including Germany, France, Italy and Spain.
Lot / Code Info
Catalog number, Lot Numbers & Expiration Dates: CAI-XLL, CXL1301L, 31 JAN 2013; CAI-XL1, CXL13011, 31 JAN 2013; CAI-XL2, CXL13012, 31 JAN 2013; CAI-XL3, CXL13013, 31 JAN 2013; CAI-XL4, CXL13014, 31 JAN 2013; CAI-XLS, CXL1301S, 31 JAN 2013
Root Cause
Nonconforming Material/Component
Action Taken
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.