Device product
Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.
Z-0716-2013
Product summary
- Event
- Event 64043
- Status
- Terminated
- Classification
- Class II
- Quantity
- 560 boxes (25 cartridges in each box)
- Official record key
device-enforcement:Z-0716-2013
Official wording
Reason: APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.
Code information: List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Unknown
APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.