i-STAT cTnI cartridges Product Usage: The i-STAT cTnl recall
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…
Why was i-STAT cTnI cartridges Product Usage: The i-STAT cTnl 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots
- Product
- 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…
- Recalling firm
- Abbott Point Of Care Inc.
- Quantity
- 7,057675 cartridges US; 772,400 cartridges OUS
- Distribution
- Worldwide Distribution - US Nationwide, International
- Recall date
- August 29, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)