FDA-Device2020-02-12Class II

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

Roche Diabetes Care, Inc.
Hazard

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

Sold states
Nationwide: Foreign: Austalia, India
Affected count
61,329 units (OUS)
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0999-2020

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