Recall Z-2169-2012 ยท MMI Immunoassay Method, Troponin Subunit
Abbott Point Of Care Inc.
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
| Date | Aug 9, 2012 (initiated Feb 1, 2012) |
| Status | Terminated |
| Reason | The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. |
| Root cause | Device Design |
| Action | Abbott Point of Care (APOC) sent an URGENT RECALL NOTICE dated February 2012 to all affected customers via e-mail and also contacted by phone. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that if their facility was performing testing at more than approximately 7500 feet above sea level, they should have an alternate test method available should they experience an issue. If they have forwarded any cartridges to another facility, they should provide a copy of the Urgent Recall Notice to them. For questions customers were i |
| Quantity | 7,057,675 cartridges US ; 772,400 OUS |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031739 | I-STAT CARDIAC TROPONIN (CTNI) TEST I-Stat Corporation, Sep 2, 2003 |