FDADecember 2, 2016device

ReliOn FastA1C Test, Software Version Revision D, REF Number 3055

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

The hazard

A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.

What to do

FDA enforcement status: Terminated

Brands named

polymer technology systemspolymerpolymer technology

Recall history

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

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ReliOn FastA1C Test, Software Version Revision D, REF Number 3055 — Recall Details · AllClear