# FDA recall Z-1265-2020

> **Abbott Point Of Care Inc.** · Class II · device recall initiated 2020-01-14.

## 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.

## 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

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1265-2020
- **Recalling firm:** Abbott Point Of Care Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-14
- **Report date:** 2020-02-26
- **Termination date:** 2021-04-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1265-2020

## Citation

> AI Analytics. FDA recall Z-1265-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1265-2020. Source: US FDA. Licensed CC0.

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