FDAFDA · Food and drugs·Recall number Z-0716-2013
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.
Published January 30, 2013 · Recall initiated: November 1, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Abbott Point of Care Canada Limited
- Distributor
- Worldwide Distribution.
- Lot
- List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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