FDA-Device2017-07-19Class III
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.
AMS Diagnostics, LLC
Hazard
Lot was not functioning properly and not exhibiting the correct physical properties.
Sold states
US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC.
Affected count
9 units
Manufactured in
1790 N Commerce Pkwy, Weston, FL, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2725-2017Don't want to check this manually?
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