FDAFDA · Food and drugs·Recall number Z-2725-2017
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.
Published July 19, 2017 · Recall initiated: February 29, 2016
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lot was not functioning properly and not exhibiting the correct physical properties.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- AMS Diagnostics, LLC
- Distributor
- US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC.
- Lot
- P/N 5409; Lot No. 15251; Exp. Date 09/2016
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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