# FDA recall Z-1263-2020

> **Abbott Point Of Care Inc.** · Class II · device recall initiated 2020-01-15.

## Product

i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative measurement of lactate, pH, pCO2, and pO2 in venous, arterial or capillary whole blood.

## Reason for recall

The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status.    CLIA recognizes two types of laboratory tests: waived and non-waived. Different CLIA standards apply to waived and non-waived tests as well as the facilities that perform these types of tests. The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine and hematocrit) and is categorized as a CLIA waived test for venous whole blood samples, meaning this cartridge could be used in a facility with a CLIA Certificate of Waiver as a waived test.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1263-2020
- **Recalling firm:** Abbott Point Of Care Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-15
- **Report date:** 2020-02-26
- **Termination date:** 2021-03-02

- **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-1263-2020

## Citation

> AI Analytics. FDA recall Z-1263-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1263-2020. Source: US FDA. Licensed CC0.

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