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FDAApril 11, 2017device

EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.

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

The hazard

Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.

What to do

FDA enforcement status: Terminated

Brands named

medica

Recall history

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

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