FDA Enforcement
Class II
Terminated
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.
Recall: Z-0716-2013
·
Reported January 30, 2013
Enforcement
- Recall Number
- Z-0716-2013
- Event ID
- 64043
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Abbott Point of Care Canada Limited
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- January 30, 2013
- Initiation Date
- November 1, 2012
- Classification Date
- January 24, 2013
- Termination Date
- June 14, 2013
- Address
- 185 Corkstown Road, N/A, Nepean, N/A, N/A, Canada
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
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 Info
List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179
Distribution
Worldwide Distribution.
Quantity
560 boxes (25 cartridges in each box)