Dimension Cardiac Troponin I Flex reagent cartridge (CTNI) recallZ-1731-2009 · Siemens Healthcare Diagnostics, Inc. · initiated Apr 8, 2008
Terminated All recalls posted in August 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
possibility of falsely elevated results
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1731-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 8, 2008
- Posted by the FDA
- Aug 12, 2009
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 4,574 cartons
- Product code
- MMI
- FDA submissions
- K010313
- 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 description
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.
Code information (models, lots, serial numbers)
Catalog Number: RF421C; Lot Number: FB9037. Expires February 6, 2009.
Other devices under the same FDA submission
2 devices cleared under K010313 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension Cardiac Troponin-I Flex reagent cartridge 10444896Siemens Healthcare Diagnostics Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall8 reports
- Dimension Cardiac Troponin-I Flex reagent cartridge 10444905Siemens Healthcare Diagnostics Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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