Abbott Point Of Care Inc.: Medical Device Recall in 2012 - (Recall #: Z-2171-2012)

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 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).

Product Classification:

Class II

Date Initiated: February 1, 2012

Date Posted: August 15, 2012

Recall Number: Z-2171-2012

Event ID: 62533

Reason for Recall:

The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.

Status: Terminated

Product Quantity: 368,149 cartridges US; 32,725 OUS

Code Information:

List number 06F25-01, 06F25-02, 03P92-25, All lots

Distribution Pattern:

Worldwide Distribution - USA including AZ and CO and internationally to Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Finland, France, Georgia, Germany, Greece, Honduras, Hong Kong, India, Ireland, Italy, Korea, Kuwait, Mauritius, Mexico, Netherland (Antilles), Nigeria, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, R.O.C., Thailand, UAE, United Kingdom, and Yemen.

Voluntary or Mandated:

Voluntary: Firm initiated