Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnos…

Recall date

May 19, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2207-2015

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc

Sold / distributed

Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, MS, MT, NC, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, and Puerto Rico; and the countries of Algeria, Austria, Bahrain, Belgiu…

Why it was recalled

System-to-system bias between the Tni-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.