Z-1265-2020Class II

i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 -

Name: Z-1265-2020 i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 -
Creator: Abbott Point Of Care Inc.
Published: 2020-01-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-01-14 / Terminated

FDA source

Abbott Point Of Care Inc. began a recall of i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement... on 2020-01-14. FDA classified it as Class II and gives the reason as "Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges and therefore will no longer...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1265-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-14
Posted: 2020-02-18
Terminated: 2021-04-12
Recalling firm: Abbott Medical
Product: i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial or capillary whole blood.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Marketed without a 510(k). Abbott Point of Care has determined that it does not have sufficient clinical evidence to fully characterize the performance of the blue i-STAT G3+ cartridges and therefore will no longer distribute the i-STAT G3+ (blue) cartridge in the United States as of May 1, 2020.
FDA root cause: No Marketing Application
Action: On January 15, 2020, the recalling firm notified customers via letters, emails, follow-up phone calls/visits by sales representatives, and a website posting at www.pointofcare.abbott. Customers were instructed to take the following actions: " During the transition, clinicians and laboratory staff should be informed that the performance of the i-STAT G3+ (BLUE) cartridge has not been fully characterized by Abbott. " Clinicians should be advised to consider a patients signs, symptoms, history, and results of other diagnostic tests when interpreting results from these cartridges. If the results do not match the patients clinical presentation, the patient sample should be retested using an alternate test method or a reference laboratory. " Report any questions or concerns you have regarding the i-STAT G3+ cartridge performance to Abbott Point of Care Technical Support at 1-800-366-8020 option 1, or via email at [email protected]. If you have forwarded any i-STAT G3+ (BLUE), 6+ (WHITE), E3+ (WHITE), and EC4+ (WHITE) cartridges to another facility, we request that you please provide a copy of this letter to them. ***Updated 4/7/2020*** On April 2, 2020, Abbott Point of Care sent an additional letter communicating the following: In response to the COVID-19 public health emergency, the U.S. Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) are allowing the use of the i-STAT CG4+(blue) and i-STAT G3+ (blue) blood gas cartridges in laboratories and facilities that hold a Certificate of Compliance or Accreditation to run tests of moderate complexity. Specifically, during the COVID-19 pandemic Abbott Point of Care may continue to distribute the i-STAT CG4+ (blue) and i-STAT G3+ (blue) cartridges, and facilities that possess a non-waived CLIA certificate (i.e., facilities that hold a Certificate of Compliance or Accreditation) may use them with venous and arterial whole blood samples as tests of moderate comp
Quantity in commerce: 4,448,525
Distribution: US Nationwide distribution.
Product codes and lots: All lots are affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1265-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1265-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-18

Product code CHL

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)