Siemens Healthcare Diagnostics, Inc. recalls Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or

Recalled December 24, 2014 · FDA recall Z-0801-2015 · Siemens Healthcare Diagnostics

Hazard

FDA Class II

Units

3,622 kits (3,572 domestic and 50 internationally)

Sold at

Worldwide Distribution: US distribution in states of: CO, FL, MN, MT, and NY; and countries of: Algeria, Argentina, Bolivia, Brazil, Bulgaria, Chile, Columbia, Czech Republic, Ecuador, Egypt, Germany, Hungary, India, Italy, Lithuania, Latvia, Pakistan, Poland, Romania, Russian Fed., Serbia, South Africa, Slovakia, Thailand, Tunisia, and Uruguay.

Product

Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →