Device Recall Medica ISE Module Calibrant A

  • Model / Serial
    P/N 5409; Lot No. 15251; Exp. Date 09/2016
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    AMS Diagnostics, LLC, 1790 N Commerce Pkwy, Weston FL 33326-3204
  • Source
    USFDA