Recall Z-2169-2012— Abbott Point Of Care Inc.

Name: FDA recall Z-2169-2012
Creator: U.S. Food and Drug Administration
Published: 2012-02-01

Class II · Terminated

Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2012-02-01, terminated 2013-02-08. It names one FDA 510(k) clearance: K031739. Product: 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: The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure..

Recalling firm: Abbott Point Of Care Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-02-01
Terminated: 2013-02-08
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 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.

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