Z-2725-2017 Class III Ongoing
FDA device recall Z-2725-2017 was initiated by AMS Diagnostics, LLC on February 29, 2016 and is designated Class III. Reason for recall: Lot was not functioning properly and not exhibiting the correct physical properties. The recall status is ongoing. Affected quantity: 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2017
- Initiation Date
- February 29, 2016
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
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.
Distribution Pattern
US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC.
Code Information
P/N 5409; Lot No. 15251; Exp. Date 09/2016