Class 3 Device Recall Medica ISE Module Calibrant A

• Date Initiated by Firm: February 29, 2016
• Create Date: July 13, 2017
• Recall Status: Open, Classified
• Recall Number: Z-2725-2017
• Recall Event ID: 77481
• Product Classification: Calibrator, multi-analyte mixture - Product Code JIX
• 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.
• Code Information: P/N 5409; Lot No. 15251; Exp. Date 09/2016
• FEI Number: 3009128555
• Recalling Firm/ Manufacturer: AMS Diagnostics, LLC; 1790 N Commerce Pkwy; Weston FL 33326-3204
• For Additional Information Contact: Samuel Burgos; 954-217-0040
• Manufacturer Reason for Recall: Lot was not functioning properly and not exhibiting the correct physical properties.
• FDA Determined Cause: Labeling mix-ups
• Action: AMS Diagnostics contacted consignees by telephone on 02/29/2017. Representatives advised consignees to discard any recalled product on hand, to be replaced with working product. Customers should not return recalled product to the firm.
• Quantity in Commerce: 9 units
• Distribution: US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.