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.
FDA Recall Z-2725-2017 · Posted None
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Recalling FirmAMS Diagnostics, LLC
Recall StatusOpen, Classified
Product CodeJIX
Date Initiated2016-02-29
Product Quantity9 units
Reason for Recall
Lot was not functioning properly and not exhibiting the correct physical properties.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
US Nationwide Distribution in the states of AZ, CA, FL, MI, NC, NY, and SC.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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