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…

Recall date

April 11, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1267-2018

FDA classification

Class II

Brand / firm

Medica Corporation

Sold / distributed

USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.