Z-2133-2012Class II

I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used...

Name: Z-2133-2012 I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used...
Creator: Abbott Point Of Care Inc.
Published: 2011-01-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-01-01 / Terminated / root cause: manufacturing process

FDA source

Abbott Point Of Care Inc. began a recall of 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... on 2011-01-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2133-2012
Classification: Class II
Status: Terminated
Initiated: 2011-01-01
Posted: 2012-08-02
Terminated: 2013-05-22
Recalling firm: Abbott Medical
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.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Abbott Point of Care, Inc sent a Urgent Recall Notice letter dated January 14, 2011 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue use of Cartridges from the identified lot. All unused cartridges will be credited and are to be returned as instructed on the enclosed Business Reply Card. If you have any questions regarding this information please contact your Abbott Point of Care Technical Support at 800-366-8020 Option 1, or your Abbott Point of Care representative.
Quantity in commerce: 52,750 cartridges
Distribution: USA ( nationwide )
Product codes and lots: List number 03P76-25 Lot number S10246A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2133-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2133-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-02

Product code CHL

K940918Class III-Stat 200 Portable Clinical AnalyzerI-Stat Corp. / cleared 1994-05-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)