Home / Recalls / Abbott Point Of Care Inc. / Z-1265-2020

Z-1265-2020 Class II Terminated

Recalled by Abbott Point Of Care Inc. — Princeton, NJ

Recall Details

Product Type
Devices
Report Date
February 26, 2020
Initiation Date
January 14, 2020
Termination Date
April 12, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,448,525

Product Description

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.

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.

Distribution Pattern

US Nationwide distribution.

Code Information

All lots are affected

Other recalls by Abbott Point Of Care Inc.

  • Z-2584-2025 Class II — i-STAT EG7+ cartridge. List Number: 03P76-25. (August 21, 2025)
  • Z-2585-2025 Class II — i-STAT EG6+ cartridge. List Number: 03P77-25. (August 21, 2025)
  • Z-2583-2025 Class II — i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940 (August 21, 2025)
  • Z-2582-2025 Class II — i-STAT CG4+ cartridge (white). List Number: 03P85-25. (August 21, 2025)
  • Z-0881-2021 Class II — Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of (December 22, 2020)
  • Z-0880-2021 Class II — Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sod (December 22, 2020)
  • Z-1262-2020 Class II — i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Pr (January 15, 2020)
  • Z-1263-2020 Class II — i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Produ (January 15, 2020)
  • Z-0761-2020 Class II — i-STAT cTnI cartridge (October 16, 2019)
  • Z-0615-2019 Class II — Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of (September 13, 2018)