Abbott i-STAT G3+ Cartridge Recall for Inaccurate Blood Gas Results
Abbott Point of Care is recalling i-STAT G3+ Cartridges (Lot N13183) because they may produce incorrectly elevated PCO2 and depressed pH results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device that may provide inaccurate diagnostic data (incorrectly elevated PCO2 and depressed pH), posing a risk of harm through misdiagnosis or mistreatment, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results. The i-STAT G3+ Cartridge is used for pH, pCO2, and pO2 measurements in the diagnosis, monitoring, and treatment of respiratory disturbances and metabolic and respiratory-based acid-base disturbances.
The recall involves 49,850 cartridges distributed worldwide, including nationwide in the USA and internationally to Canada. The specific lot number is N13183, and the list number is 03P78-25. This recall is classified as Class II by the FDA.
Healthcare providers and consumers should stop using the affected cartridges and contact Abbott Point of Care for further instructions or replacement. No specific instructions for end-users are provided in the source text beyond the determination of the defect.
The recalled product
- Product
- i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
- Manufacturer
- Abbott Point Of Care Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- List number 03P78-25 :Lot number N13183
Distribution
Distributed nationwide across the United States.
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