Z-0716-2013Class II

Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro...

Name: Z-0716-2013 Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro...
Creator: Abbott Point of Care Canada Limited
Published: 2012-11-01
License: https://open.fda.gov/license/

Abbott Point of Care Canada Limited / initiated 2012-11-01 / Terminated / root cause: labeling and UDI

FDA source

Abbott Point of Care Canada Limited began a recall of 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... on 2012-11-01. FDA classified it as Class II and gives the reason as "APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0716-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-01
Posted: 2013-01-24
Terminated: 2013-06-14
Recalling firm: Abbott Point of Care Canada Limited
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.
Product code: MMI Immunoassay Method, Troponin Subunit
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: APOC sent an "IMPORTANT PRODUCT INFORMATION" letter dated October 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Abbott Point Of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point Of Care representative for questions regarding this information.
Quantity in commerce: 560 boxes (25 cartridges in each box)
Distribution: Worldwide Distribution.
Product codes and lots: List number 06F15-03, O6F15-04, 03P90-25, 600-9009-25 Lot number P12179

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0716-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0716-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-24

Product code MMI

K031739Class III-Stat Cardiac Troponin (Ctni) TestI-Stat Corporation / cleared 2003-09-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)