Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk of stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
FDA Recall Z-1731-2009 · Posted 2009-08-12
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeMMI
Date Initiated2008-04-08
Date Terminated2009-08-13
Product Quantity4,574 cartons
Reason for Recall
possibility of falsely elevated results
Firm Action
Siemens Healthcare Diagnostics issued a letter to their customers starting April 8, 2008 informing them of the problem and to discontinue use of the product.
Further questions should be addressed to Siemens Healthcare Diagnostics, Inc. at 1-800-441-9250.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- Including countries of the United States, Bahamas, Belgium, Czech Republic, France, Germany, Italy, Poland, Portugal, Saudi Arabia, Spain, South Korea, and Slovakia.
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.
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