Recall Z-0716-2013— Abbott Point of Care Canada Limited
Class II · Terminated
Class II FDA medical device recall by Abbott Point of Care Canada Limited, initiated 2012-11-01, terminated 2013-06-14. It names one FDA 510(k) clearance: K031739. 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.. 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..
- Recalling firm
- Abbott Point of Care Canada Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-01
- Terminated
- 2013-06-14
- Firm location
- Nepean, N/A, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.