The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2133-2012·Announced 2012-08-08

Abbott i-Stat EG7 Cartridges Recalled for Inaccurate PCO2 Results

Abbott Point of Care is recalling 52,750 i-Stat EG7 cartridges because they may produce falsely low PCO2 readings if stored at room temperature for four weeks or longer.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where inaccurate results could impact patient care, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Abbott Point of Care Inc. is recalling 52,750 units of the i-Stat EG7+ Cartridge. These medical devices are used to quantitatively measure sodium, potassium, ionized calcium, oxygen, and carbon dioxide partial pressure in whole blood samples. The affected units are identified by List number 03P76-25 and Lot number S10246A.

The recall was initiated because the cartridges may generate falsely depressed PCO2 (partial pressure of carbon dioxide) results for samples above 26 mm Hg if the cartridges have been stored at room temperature for four weeks or longer. This inaccuracy could potentially affect clinical decision-making based on the test results.

The affected products were distributed nationwide in the United States. Healthcare facilities and users should stop using the affected cartridges and contact Abbott Point of Care for further instructions or replacement.

The recalled product

Product
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.
Manufacturer
Abbott Point Of Care Inc.
Category
Medical Device — Point-of-Care Testing
Hazard
Affected units
52,750

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • List number 03P76-25 Lot number S10246A

Distribution

Distributed nationwide across the United States.

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