Z-0637-2012

ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in...

Name: Z-0637-2012 ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in...
Creator: Microgenics Corporation
Published: 2011-12-14
License: https://open.fda.gov/license/

Microgenics Corporation / initiated 2011-12-14 / Terminated / root cause: manufacturing process

FDA source

Microgenics Corporation began a recall of ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. Catalog Numbers & Description... on 2011-12-14. The reason FDA records is "Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0637-2012
Status: Terminated
Initiated: 2011-12-14
Posted: 2012-01-11
Terminated: 2012-10-26
Recalling firm: Microgenics Corporation
Product: 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;
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges.
Root cause tag: manufacturing process
FDA 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 in commerce: 25,113 Kits
Distribution: Nationwide and Worldwide, including Germany, France, Italy and Spain.
Product codes and lots: 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

Product code JJY

K061196Class ICardioimmune Xl Cardiac Marker ControlMicrogenics Corp. / cleared 2006-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)