Home / Recalls / Abbott Point of Care Canada Limited / Z-0716-2013

Z-0716-2013 Class II Terminated

Recalled by Abbott Point of Care Canada Limited — Nepean, N/A

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