Abbott Point Of Care Inc.: Medical Device Recall in 2020 - (Recall #: Z-1265-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 14, 2020

Date Posted: February 26, 2020

Recall Number: Z-1265-2020

Event ID: 84730

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.

Status: Terminated

Product Quantity: 4,448,525

Code Information:

All lots are affected

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated