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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Abbott Point Of Care Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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 Codes/Lot Numbers:
510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2237-2012
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