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).
Reported: December 24, 2014 Initiated: October 27, 2014 #Z-0801-2015
Product Description
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).
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 3,622 kits (3,572 domestic and 50 internationally)
- Distribution
- 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.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 3,622 kits (3,572 domestic and 50 internationally).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2014. Severity: Moderate. Recall number: Z-0801-2015.
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