Z-1306-2014Class II

i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of...

Name: Z-1306-2014 i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of...
Creator: Abbott Point Of Care Inc.
Published: 2014-01-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-01-01 / Terminated / root cause: manufacturing process

FDA source

Abbott Point Of Care Inc. began a recall of i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and... on 2014-01-01. FDA classified it as Class II and gives the reason as "Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results". 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-1306-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-01
Posted: 2014-03-27
Terminated: 2014-10-20
Recalling firm: Abbott Medical
Product: i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: APOC sent an Urgent Recall Notice dated January 2014 via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product and provide a copy of this letter to any institution that was forwarded the affected product. All unused cartridges will be credited and are to be returned as instructed on the enclosed Business Reply Card. To ensure continuity of supply at their facility, customers were instructed to follow their standard process to place an order or call Customer Sedrvice at 1-800-323-9100, Option #2, then Option #9). Customers with questions were instructed to contact Abbott Point of Care Technical Support at 1-800-366-8020, Option 1 of their Abbott Point of Care representative. For questions regarding this recall call 800-323-9100.
Quantity in commerce: 48, 450 US, 1400 OUS (49,850 catridges)
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Product codes and lots: List number 03P78-25 :Lot number N13183

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1306-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1306-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-27

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)