Home / Recalls / Medical Devices
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 Modu
Recalled July 19, 2017 · FDA recall Z-2725-2017 · AMS Diagnostics
Hazard
Lot was not functioning properly and not exhibiting the correct physical properties. · FDA Class III
Units
9 units
Sold at
US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC.
Description
Lot was not functioning properly and not exhibiting the correct physical properties.
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.
Manufacturer(s)
AMS Diagnostics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →