FDA recall Z-0999-2020

Roche Diabetes Care, Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

Nationwide: Foreign: Austalia, India

Key facts

Status: Terminated
Initiation date: 2019-12-11
Report date: 2020-02-12
Termination date: 2022-07-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Indianapolis, IN, United States

Primary source

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