CLASS II Device recall · Reported 8 Aug 2012 · FDA Enforcement Report

I-stat EG7+ Cartridge Abbott Point of Care, Princeton, NJ recalled

Abbott Point Of Care is recalling I-stat EG7+ Cartridge Abbott Point of Care, Princeton, NJ, distributed nationwide in the US. The recall was initiated on 1 Jan 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesList number 03P76-25 Lot number S10246A

Quantity recalled52,750 cartridges

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-2133-2012
FDA event ID: 62371
Recalling firm: Abbott Point Of Care, Princeton, NJ
Classification: Class II
Status: Terminated
Recall initiated: 1 Jan 2011
FDA classified: 2 Aug 2012
Reported: 8 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

1 Jan 2011	Recall initiated by company
2 Aug 2012	Classified by FDA	+579 days
8 Aug 2012	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

i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.

Where it was distributed

USA ( nationwide )

Nationwide

Questions about this recall

Is I-stat EG7+ Cartridge Abbott Point of Care, Princeton, NJ recalled?

Yes. Abbott Point Of Care recalled I-stat EG7+ Cartridge Abbott Point of Care, Princeton, NJ on 1 Jan 2011. The recall is Class II and its status is Terminated. Recall number Z-2133-2012.

Why was it recalled?

i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer.

Which lots are affected?

List number 03P76-25 Lot number S10246A

Where was it sold?

USA ( nationwide )

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

More recalls from Abbott Point Of Care

All 31

Reported	Class	Recall	Company	Reason	Where
6 May 2026Device	CLASS II	i-STAT EG6+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide
6 May 2026Device	CLASS II	i-STAT EG7+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide
6 May 2026Device	CLASS II	i-STAT G3+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide
24 Sep 2025Device	CLASS II	i-STAT EG7+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide
24 Sep 2025Device	CLASS II	i-STAT CG8+ cartridge recalled by Abbott Point Of Care	Abbott Point Of Care	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide