Class 2 Device Recall iSTAT G3 cartridge (blue)

• Date Initiated by Firm: January 14, 2020
• Date Posted: February 18, 2020
• Recall Status: Terminated on April 12, 2021
• Recall Number: Z-1265-2020
• Recall Event ID: 84730
• Product Classification: Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
• 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.
• Code Information: All lots are affected
• Recalling Firm/ Manufacturer: Abbott Point Of Care Inc.; 400 College Rd E; Princeton NJ 08540-6607
• For Additional Information Contact: Stephanie Radek; 609-454-9000
• Manufacturer 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 Determined 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 in Commerce: 4,448,525
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.