FDAClass IIApril 2, 2014

i-STAT G3+ Cartridge pH recall

i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and…

Why was i-STAT G3+ Cartridge pH 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.

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 03P78-25 :Lot number N13183

Product
i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and…
Recalling firm
Abbott Point Of Care Inc.
Quantity
48, 450 US, 1400 OUS (49,850 catridges)
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Recall date
April 2, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls