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;
FDA Recall Z-0637-2012 · Posted 2012-01-11
Recalling FirmMicrogenics Corporation
Recall StatusTerminated
Product CodeJJY
Date Initiated2011-12-14
Date Terminated2012-10-26
Product Quantity25,113 Kits
Reason for Recall
Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide and Worldwide, including Germany, France, Italy and Spain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.