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Recall Observatory FDA recall evidence

Device 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.

Z-1306-2014

January 01, 2014

Class II

Product summary

Firm
Abbott Point Of Care Inc.
Event
Event 67513
Status
Terminated
Classification
Class II
Quantity
48, 450 US, 1400 OUS (49,850 catridges)
Official record key
device-enforcement:Z-1306-2014

Official wording

Reason: 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.

Code information: List number 03P78-25 :Lot number N13183

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.