Recall Z-2171-2012— Abbott Point Of Care Inc.

Name: FDA recall Z-2171-2012
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: K051433. Product: i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).. 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

K051433 — I-STAT CREATINE KINASE MB (CK-MB)I-Stat Corporation·cleared 2005-12-15

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 CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).

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.