Medical device recalls Moderate risk

Roche Diabetes Care, Inc. recalls ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020

Recall date
December 11, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0999-2020
FDA classification
Class II
Brand / firm
Roche Diabetes Care, Inc.
Sold / distributed
Nationwide: Foreign: Austalia, India

Why it was recalled

Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions

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

What was recalled

ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020

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