CLASS II Device recall · Reported 15 Aug 2012 · FDA Enforcement Report

i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat recalled

Abbott Point Of Care is recalling i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro, distributed in Arizona, Colorado, Georgia. The recall was initiated on 1 Feb 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesList number 06F15-03, 06F15-04, 03P90-23, 600-9009-25 All lots

Quantity recalled7,057,675 cartridges US ; 772,400 OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2169-2012
FDA event ID: 62533
Recalling firm: Abbott Point Of Care, Princeton, NJ
Classification: Class II
Status: Terminated
Recall initiated: 1 Feb 2012
FDA classified: 9 Aug 2012
Reported: 15 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

1 Feb 2012	Recall initiated by company
9 Aug 2012	Classified by FDA	+190 days
15 Aug 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.

Product as listed by the FDA

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.

Where it was distributed

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.

Arizona Colorado Georgia

Questions about this recall

Why was it recalled?

The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.

Which lots are affected?

List number 06F15-03, 06F15-04, 03P90-23, 600-9009-25 All lots

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 62533

This product is part of a recall event; the main page for the event is i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat recalled.

Reported	Class	Recall	Company	Reason	Where
15 Aug 2012	CLASS II	i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat recalled	Abbott Point Of Care	Device Malfunction	AZ, CO, GA
15 Aug 2012	CLASS II	i-Stat Ck-mp cartridges Abbott Point of Care Inc. recalled	Abbott Point Of Care	Other	AZ, CO, GA

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