Device 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.
Z-2725-2017
Product summary
- Event
- Event 77481
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 9 units
- Official record key
device-enforcement:Z-2725-2017
Official wording
Reason: Lot was not functioning properly and not exhibiting the correct physical properties.
Code information: P/N 5409; Lot No. 15251; Exp. Date 09/2016
Distribution pattern: US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC.
Derived failure modes
-
Unknown
Lot was not functioning properly and not exhibiting the correct physical properties.