Z-2169-2012Class II

i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the...

Name: Z-2169-2012 i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the...
Creator: Abbott Point Of Care Inc.
Published: 2012-02-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-02-01 / Terminated / root cause: design

FDA source

Abbott Point Of Care Inc. began a recall of i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in... on 2012-02-01. FDA classified it as Class II and gives the reason as "The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure". 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-2169-2012
Classification: Class II
Status: Terminated
Initiated: 2012-02-01
Posted: 2012-08-09
Terminated: 2013-02-08
Recalling firm: Abbott Medical
Product: i-Stat cTnl cartridges Abbott Point of Care Inc. 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 troponin I measurements can 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. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
Root cause tag: design
FDA root cause: Device Design
Action: Abbott Point of Care (APOC) sent an URGENT RECALL NOTICE dated February 2012 to all affected customers via e-mail and also contacted by phone. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that if their facility was performing testing at more than approximately 7500 feet above sea level, they should have an alternate test method available should they experience an issue. If they have forwarded any cartridges to another facility, they should provide a copy of the Urgent Recall Notice to them. For questions customers were instructed to call 800-366-8020, Option 1 or contact their Abbott Point of Care representative. For questions regarding this recall call 609-454-9000.
Quantity in commerce: 7,057,675 cartridges US ; 772,400 OUS
Distribution: Worldwide Distribution - USA including AZ and CO and internationally to Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Finland, France, Georgia, Germany, Greece, Honduras, Hong Kong, India, Ireland, Italy, Korea, Kuwait, Mauritius, Mexico, Netherland (Antilles), Nigeria, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, R.O.C., Thailand, UAE, United Kingdom, and Yemen.
Product codes and lots: List number 06F15-03, 06F15-04, 03P90-23, 600-9009-25 All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2169-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2169-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-09
Z-2170-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-09
Z-2171-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-09

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)