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.
Reported: April 2, 2014 Initiated: January 1, 2014 #Z-1306-2014
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Abbott Point Of Care Inc.
- Units Affected
- 48, 450 US, 1400 OUS (49,850 catridges)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Canada.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Abbott Point Of Care Inc.. Units affected: 48, 450 US, 1400 OUS (49,850 catridges).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 2, 2014. Severity: Moderate. Recall number: Z-1306-2014.
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