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FDAFebruary 29, 2016device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

ams diagnosticsams

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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