Recall Z-0801-2015— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0801-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-27

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2014-10-27, terminated 2017-03-10. It names one FDA 510(k) clearance: K991795. 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)..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-27
Terminated: 2017-03-10
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K991795 — IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5Diagnostic Products Corp.·cleared 1999-06-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.