FDA Device

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;

Hazard

Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges.

What You Should Do

Remedy

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.

Products

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-X
Brand
Microgenics Corporation
UPC
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

Units Affected

25,113 Kits