Z-2237-2012Class II

i-STAT cTnI cartridges

Name: Z-2237-2012 i-STAT cTnI cartridges
Creator: Abbott Point Of Care Inc.
Published: 2012-03-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-03-07 / Terminated / root cause: design

FDA source

Abbott Point Of Care Inc. began a recall of i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized... on 2012-03-07. FDA classified it as Class II and gives the reason as "Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2237-2012
Classification: Class II
Status: Terminated
Initiated: 2012-03-07
Posted: 2012-08-22
Terminated: 2013-02-19
Recalling firm: Abbott Medical
Product: i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user documentation.
Root cause tag: design
FDA root cause: Device Design
Action: Abbott Point of Care (APOC) sent an Urgent Recall Notice letters, via Fed Ex on March 07, 2012 to all affected customers. APOC sent an important product information update on July 19, 2012 to all of their affected customers. The letter identified the affected product, problem and actions to be taken. Customers are asked to review the information included as it may pertain to their cartridges. Customers were instructed that if the affected product have been forwarded to another facility, provide a copy of this letter to them. For additional information, contact APOC at 800-366-8020 option 1 or your Abbott Point of Care representative.
Quantity in commerce: 7,057675 cartridges US; 772,400 cartridges OUS
Distribution: Worldwide Distribution - US Nationwide, International
Product codes and lots: 510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2237-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2237-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)