Reported Aug 29, 2012 · Terminated
i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative…
Abbott Point Of Care Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Point Of Care Inc. · 400 College Rd E · Princeton, NJ · 08540-6607
Is this the product you have?
- i-STAT cTnI cartridges Product UsageThe 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
- Lot codes and dates
510(K)K031739 List Number 06F15-0306F15-0403P90-25600-9009-25 All lots
- Amount recalled
- 7,057675 cartridges US; 772,400 cartridges OUS
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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