Enforcement Report - Week of August 29, 2012
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Product Detail
| 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. |
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| Recall Number | Z-2237-2012 |
| Classification | Class II |
| Code Info | 510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots |
| Product Distributed Qty | 7,057675 cartridges US; 772,400 cartridges OUS |
| 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. |
Event Detail
| Event Id | 62410 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Abbott Point Of Care Inc. |
| City | Princeton |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-03-07 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - US Nationwide, International |
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