Class 2 Device Recall iStat cTnl cartridges

• Date Initiated by Firm: February 01, 2012
• Date Posted: August 09, 2012
• Recall Status: Terminated on February 08, 2013
• Recall Number: Z-2169-2012
• Recall Event ID: 62533
• 510(K)Number: K031739
• Product Classification: Immunoassay method, troponin subunit - Product Code MMI
• 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.
• Code Information: List number 06F15-03, 06F15-04, 03P90-23, 600-9009-25 All lots
• Recalling Firm/ Manufacturer: Abbott Point Of Care Inc.; 400 College Rd E; Princeton NJ 08540-6607
• For Additional Information Contact: Mr. Larry Krasley; 609-454-9272
• Manufacturer Reason for Recall: The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MMI