AMS Diagnostics, LLC recalls Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Mod…

Recall date

February 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2725-2017

FDA classification

Class III

Brand / firm

AMS Diagnostics, LLC

Sold / distributed

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

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.