IMMULITE/IMMULITE 1000 CK-MB LKMB --- Catalog number: LKMB1 (100 tests), LKMB5 (500 tests) --- Test code: CMB Color: Dark Blue. For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.

Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE platforms.

Siemens sent an "URGENT DEVICE RECALL" letter dated January 2012 to all affected customers. The letter identifies the product , problem, and actions to be taken by the customers. Siemens recommends that customers reestablish their own medians and reference ranges, in line with the recommendations made in the IFU for these products. A Field Correction Effectiveness Check form was included for customers to complete and return to the firm. Customers with questions or who need additional information should contact their Siemens Technical Solutions Center.