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Terminated

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.

FDA Recall Z-2169-2012 · Posted 2012-08-09

Recalling FirmAbbott Point Of Care Inc.
Recall StatusTerminated
Product CodeMMI
Date Initiated2012-02-01
Date Terminated2013-02-08
Product Quantity7,057,675 cartridges US ; 772,400 OUS

Reason for Recall

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031739I-STAT CARDIAC TROPONIN (CTNI) TESTI-Stat Corporation · 2003-09-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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