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Medica Corporation recalls EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for e
Recalled April 4, 2018 · FDA recall Z-1267-2018 · Medica
Hazard
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values. · FDA Class II
Sold at
USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.
Description
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.
Product
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.
Manufacturer(s)
Medica Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →