i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Enforcement
- Recall Number
- Z-2237-2012
- Event ID
- 62410
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Abbott Point Of Care Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 29, 2012
- Initiation Date
- March 7, 2012
- Classification Date
- August 21, 2012
- Termination Date
- February 19, 2013
- Address
- 400 College Rd E, N/A, Princeton, NJ, 08540-6607, United States
Description
i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user documentation.
510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots
Worldwide Distribution - US Nationwide, International
7,057675 cartridges US; 772,400 cartridges OUS