FDA Recall Terminated

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.

Recall: Z-2237-2012 · Initiated March 7, 2012

Recall

Recall Number: Z-2237-2012
Event Number: 62410
Firm: Abbott Point Of Care Inc.
FEI Number: 2245578
Product Code: MMI
Status: Terminated
Root Cause: Device Design
Initiated: March 7, 2012
Posted: August 22, 2012
Terminated: February 19, 2013
Address: 400 College Rd E, Princeton, NJ, 08540-6607

Description

Reason

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.

Action

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.

Distribution

Worldwide Distribution - US Nationwide, International

Quantity

7,057675 cartridges US; 772,400 cartridges OUS