Recall Z-2237-2012— Abbott Point Of Care Inc.

Name: FDA recall Z-2237-2012
Creator: U.S. Food and Drug Administration
Published: 2012-03-07

Class II · Terminated

Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2012-03-07, terminated 2013-02-19. It names one FDA 510(k) clearance: K031739. Product: 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.. 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..

Recalling firm: Abbott Point Of Care Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-03-07
Terminated: 2013-02-19
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K031739 — I-STAT CARDIAC TROPONIN (CTNI) TESTI-Stat Corporation·cleared 2003-09-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.