Recall Z-0998-2020— Roche Diabetes Care, Inc.

Name: FDA recall Z-0998-2020
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. It names one FDA 510(k) clearance: K131029. Product: Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001. 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

510(k) clearances named in this recall

1 on FDA's record

K131029 — ACCU-CHEK AVIVA PLUS TEST STRIPRoche Diagnostics Operations, Inc.·cleared 2013-08-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001

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.