Z-2169-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 15, 2012
- Initiation Date
- February 1, 2012
- Termination Date
- February 8, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,057,675 cartridges US ; 772,400 OUS
Product Description
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.
Reason for Recall
The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
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.
Code Information
List number 06F15-03, 06F15-04, 03P90-23, 600-9009-25 All lots