Z-0716-2013 Class II Terminated
FDA device recall Z-0716-2013 was initiated by Abbott Point of Care Canada Limited on November 1, 2012 and is designated Class II. Reason for recall: APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack. The recall status is terminated (terminated June 14, 2013). Affected quantity: 560 boxes (25 cartridges in each box).
Recall Details
- Product Type
- Devices
- Report Date
- January 30, 2013
- Initiation Date
- November 1, 2012
- Termination Date
- June 14, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 560 boxes (25 cartridges in each box)
Product Description
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.
Reason for Recall
APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.
Distribution Pattern
Worldwide Distribution.
Code Information
List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179