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. The i-Stat EG7 cartridge is, 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
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 )
Questions about this recall
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 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.
More recalls from Abbott Point Of Care
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | i-STAT EG6+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT EG7+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT G3+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT EG7+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
| Device | CLASS II | i-STAT CG8+ cartridge recalled by Abbott Point Of Care | Abbott Point Of Care | Other | Nationwide |
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