Abbott Point of Care Canada Limited: Medical Device Recall in 2013 - (Recall #: Z-0716-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 1, 2012

Date Posted: January 30, 2013

Recall Number: Z-0716-2013

Event ID: 64043

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.

Status: Terminated

Product Quantity: 560 boxes (25 cartridges in each box)

Code Information:

List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179

Distribution Pattern:

Worldwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated