Device product
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.
Z-2237-2012
Product summary
- Event
- Event 62410
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,057675 cartridges US; 772,400 cartridges OUS
- Official record key
device-enforcement:Z-2237-2012
Official wording
Reason: 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.
Code information: 510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots
Distribution pattern: Worldwide Distribution - US Nationwide, International
Derived failure modes
-
Unknown
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.