RecallDepth

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.

Company
Ams Diagnostics, Llc
Recall Initiated
February 29, 2016
Recall Number
Z-2725-2017
Quantity
9 units
Firm Location
Weston, FL

Reason for Recall

Lot was not functioning properly and not exhibiting the correct physical properties.

Distribution

US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC.

Lot / Code Info

P/N 5409; Lot No. 15251; Exp. Date 09/2016

Root Cause

Labeling mix-ups

Action Taken

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.

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