# FDA recall Z-0880-2021

> **Abbott Point Of Care Inc.** · Class II · device recall initiated 2020-12-22.

## Product

Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood    List Number: 03P88-25

## Reason for recall

Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above  Where * = lot letter A, K, L, M, N, W or Y.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0880-2021
- **Recalling firm:** Abbott Point Of Care Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-22
- **Report date:** 2021-01-27
- **Termination date:** 2023-09-01

- **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-0880-2021

## Citation

> AI Analytics. FDA recall Z-0880-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0880-2021. Source: US FDA. Licensed CC0.

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