CLASS II Device recall · Reported 2 Apr 2014 · FDA Enforcement Report

i-STAT G3+ Cartridge pH, pCO2 recalled by Abbott Point Of Care

Abbott Point Of Care is recalling i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring, distributed nationwide in the US. The recall was initiated on 1 Jan 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesList number 03P78-25 :Lot number N13183

Quantity recalled48, 450 US, 1400 OUS (49,850 catridges)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1306-2014
FDA event ID: 67513
Recalling firm: Abbott Point Of Care, Princeton, NJ
Classification: Class II
Status: Terminated
Recall initiated: 1 Jan 2014
FDA classified: 27 Mar 2014
Reported: 2 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

1 Jan 2014	Recall initiated by company
27 Mar 2014	Classified by FDA	+85 days
2 Apr 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

List number 03P78-25 :Lot number N13183

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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