Siemens Healthcare Diagnostics, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Catalog Number: RF421C, Lot Number: FB9037. Expires February 6, 2009.
Products Sold
Catalog Number: RF421C; Lot Number: FB9037. Expires February 6, 2009.
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimension Clin due to possibility of falsely elevated results. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
possibility of falsely elevated results
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026