Recall Z-0999-2020— Roche Diabetes Care, Inc.

Name: FDA recall Z-0999-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-11

Class II · Terminated

Class II FDA medical device recall by Roche Diabetes Care, Inc., initiated 2019-12-11, terminated 2022-07-08. FDA's recall record names no specific 510(k) clearance for this event. Product: ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020. Reason: 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.

Recalling firm: Roche Diabetes Care, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-12-11
Terminated: 2022-07-08
Firm location: Indianapolis, IN, United States

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.