Abbott Point Of Care Inc.: 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.

Recall number

Z-1265-2020

Recalling firm

Abbott Point Of Care Inc.

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.

Status

Terminated

Initiated

2020-01-14

Posted

2020-02-18

Terminated

2021-04-12

Reason

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.

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 techsvc@apoc.abbott.com. 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

4,448,525

Distribution

US Nationwide distribution.

Lot, serial or model codes

All lots are affected

510(k) numbers

not on file

PMA numbers

not on file

Product code

CHL

Firm FEI

2245578

Firm city

Princeton

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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