Recall Z-2725-2017— AMS Diagnostics, LLC
Class III · Ongoing
Class III FDA medical device recall by AMS Diagnostics, LLC, initiated 2016-02-29. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Lot was not functioning properly and not exhibiting the correct physical properties..
- Recalling firm
- AMS Diagnostics, LLC
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2016-02-29
- Firm location
- Weston, FL, United States
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.
Reason for recall
Lot was not functioning properly and not exhibiting the correct physical properties.
Data sourced from openFDA. This site is unofficial and independent of the FDA.