Z-2170-2012 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
- 1,004,200 cartridges US; 54,200 cartridges OUS
Product Description
i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
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 06F30-01, 06F30-02, 03P93-25, 600-9010-25 All lots