Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Medica ISE Module Calibrant A Recalled by AMS Diagnostics, LLC Due to Lot was not functioning properly and not exhibiting...

Name: 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 sys
Brand: AMS Diagnostics, LLC

Date: February 29, 2016

Company: AMS Diagnostics, LLC

Status: Ongoing

Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AMS Diagnostics, LLC directly.

Affected Products

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.

Quantity: 9 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

About AMS Diagnostics, LLC

AMS Diagnostics, LLC has 4 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report