Severity
Moderate
FDA Devices recall · Reported August 8, 2012
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.
Abbott Point Of Care Inc. recalled I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is… - a moderate-severity action.
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is… was recalled by Abbott Point Of Care Inc. in August 8, 2012. Reason: i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at r…. Check the official notice for the remedy. Verify recall #Z-2133-2012 with the FDA Devices before acting.
The recall
Abbott Point Of Care Inc. issued this moderate-severity FDA Devices recall-i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at r….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2133-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2133-2012) was formally reported on August 8, 2012, with the manufacturer initiating the action on January 1, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. Abbott Point Of Care Inc. is listed as the recalling firm, operating out of Princeton, NJ. Federal records list the affected scope as 52,750 cartridges.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: USA ( nationwide ). Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
52,750 cartridges
Related Recalls
6
3 from same agency
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.
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2133-2012 |
| Date reported | August 8, 2012 |
| Date initiated | January 1, 2011 |
| Recalling firm | Abbott Point Of Care Inc. |
| Firm location | Princeton, NJ |
| Affected scope | 52,750 cartridges |
| Distribution | USA ( nationwide ) |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 8, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.