Z-1731-2009

Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimension Clinical...

Name: Z-1731-2009 Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimension Clinical...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2008-04-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-04-08 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay... on 2008-04-08. The reason FDA records is "possibility of falsely elevated results". 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-1731-2009
Status: Terminated
Initiated: 2008-04-08
Posted: 2009-08-12
Terminated: 2009-08-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: possibility of falsely elevated results
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 4,574 cartons
Distribution: Worldwide Distribution -- Including countries of the United States, Bahamas, Belgium, Czech Republic, France, Germany, Italy, Poland, Portugal, Saudi Arabia, Spain, South Korea, and Slovakia.
Product codes and lots: Catalog Number: RF421C; Lot Number: FB9037. Expires February 6, 2009.

Product code MMI

K010313Class IIDimension Ctni Flex Reagent CartridgeDade Behring, Inc. / cleared 2001-04-20

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)