Recall Z-2185-2018— Roche Diabetes Care, Inc.

Name: FDA recall Z-2185-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-07

Class II · Terminated

Class II FDA medical device recall by Roche Diabetes Care, Inc., initiated 2018-05-07, terminated 2020-01-16. It names one FDA 510(k) clearance: K131029. Product: Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.. Reason: The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detected once inserted, or biased results, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result..

Recalling firm: Roche Diabetes Care, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-07
Terminated: 2020-01-16
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 Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

Reason for recall

The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detected once inserted, or biased results, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result.

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