i-Stat CK-MP cartridges Abbott Point of Care Inc. The recall
i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine…
Why was i-Stat CK-MP cartridges Abbott Point of Care Inc. The recalled?
The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
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?
List number 06F25-01, 06F25-02, 03P92-25, All lots
- Product
- i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine…
- Recalling firm
- Abbott Point Of Care Inc.
- Quantity
- 368,149 cartridges US; 32,725 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, Mauritius, Mexico, Netherland (Antilles), Nigeria, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, R.O.C., Thailand, UAE, United Kingdom, and Yemen.
- Recall date
- August 15, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)