Abbott Point Of Care Inc.: Medical Device Recall in 2012 - (Recall #: Z-2237-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 7, 2012

Date Posted: August 29, 2012

Recall Number: Z-2237-2012

Event ID: 62410

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.

Status: Terminated

Product Quantity: 7,057675 cartridges US; 772,400 cartridges OUS

Code Information:

510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots

Distribution Pattern:

Worldwide Distribution - US Nationwide, International

Voluntary or Mandated:

Voluntary: Firm initiated