# FDA recall Z-2725-2017

> **AMS Diagnostics, LLC** · Class III · device recall initiated 2016-02-29.

## Product

Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module;     Product Usage:  Calibrations of ISE Model for integrated electrolyte system analysis.

## Reason for recall

Lot was not functioning properly and not exhibiting the correct physical properties.

## Distribution

US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC.

## Key facts

- **Recall number:** Z-2725-2017
- **Recalling firm:** AMS Diagnostics, LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2016-02-29
- **Report date:** 2017-07-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Weston, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2725-2017

## Citation

> AI Analytics. FDA recall Z-2725-2017. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2725-2017. Source: US FDA. Licensed CC0.

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