Home / Recalls / Roche Diabetes Care, Inc. / Z-2766-2019

Z-2766-2019 Class II Terminated

Recalled by Roche Diabetes Care, Inc. — Indianapolis, IN

FDA device recall Z-2766-2019 was initiated by Roche Diabetes Care, Inc. on Jun 12, 2017 and is designated Class II. Reason for recall: Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on). The recall status is terminated (terminated Oct 30, 2020).

Recall Details

Product Type: Devices
Report Date: Oct 9, 2019
Initiation Date: Jun 12, 2017
Termination Date: Oct 30, 2020
Voluntary/Mandated: Voluntary: Firm initiated

Product Description

Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. b. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Accu-Chek Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). c. 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

Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).

Distribution Pattern

Worldwide distribution - US Nationwide distribution.

Code Information

Serial numbers less than xxx25525056 Updated serial numbers on 10/12/2019: Performa II: Between XXX20000000 and XXX25525056 Updated 10/18/2019: Performa II: from XXX20000000 to XXX25525056

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2766-2019
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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