# FDA recall Z-1296-2019

> **Abbott Laboratories, Inc** · Class II · device recall initiated 2018-08-28.

## Product

Abbott ARCHITECT cSystems ICT Module, REF 09D28-03.    Product Usage:  The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.

## Reason for recall

There is a potential to generate falsely elevated serum or plasma chloride results when using the product.

## Distribution

Worldwide Distribution - US Nationwide in the states of AR, CA, CT, FL, IA, IN, LA, MA, MD, MS, NJ, NY, PA, SC, TX, VT, WA, and WV.  There was government distribution and no military distribution.  Foreign distribution was made to Australia, China, Hong Kong, and New Zealand.

## Key facts

- **Recall number:** Z-1296-2019
- **Recalling firm:** Abbott Laboratories, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-28
- **Report date:** 2019-05-15
- **Termination date:** 2020-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1296-2019

## Citation

> AI Analytics. FDA recall Z-1296-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1296-2019. Source: US FDA. Licensed CC0.

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