i-STAT cTnI cartridges Product Usage: 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 I troponin measurement cane 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.
This recall has been terminated (originally issued August 22, 2012).
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- March 7, 2012
- Posted
- August 22, 2012
- Terminated
- February 19, 2013
- Recall Number
- Z-2237-2012
- Quantity
- 7,057675 cartridges US; 772,400 cartridges OUS
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user documentation.
Distribution
Worldwide Distribution - US Nationwide, International
Lot / Code Info
510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots
Root Cause
Device Design
Action Taken
Abbott Point of Care (APOC) sent an Urgent Recall Notice letters, via Fed Ex on March 07, 2012 to all affected customers. APOC sent an important product information update on July 19, 2012 to all of their affected customers. The letter identified the affected product, problem and actions to be taken. Customers are asked to review the information included as it may pertain to their cartridges. Customers were instructed that if the affected product have been forwarded to another facility, provide a copy of this letter to them. For additional information, contact APOC at 800-366-8020 option 1 or your Abbott Point of Care representative.