—#81854

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.

FDA product code: MMI — Immunoassay Method, Troponin Subunit
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K010313
Affected lot / code info: Catalog Number: RF421C; Lot Number: FB9037. Expires February 6, 2009.

Why it was recalled

possibility of falsely elevated results

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

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.

Timeline

Recall initiated: 2008-04-08
Posted by FDA: 2009-08-12
Terminated: 2009-08-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81854. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.