FDAFDA · Food and drugs·Recall number Z-0801-2015
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).
Published December 24, 2014 · Recall initiated: October 27, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- 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.
- Lot
- Catalog #'s: 1) LSKTI1 and 2) LSKTI1(D); Siemens Material Number (SMN): 1) 10642238 (US) and 2) 10381014 (OUS); Lot Numbers: 319, 321, 322, 323 and D319, D321 and D322.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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