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Accu-Chek Performa II Meter - Product Usage: a. The… recallZ-2766-2019 · Roche Diabetes Care, Inc. · initiated Jun 12, 2017

Class II Terminated All recalls posted in September 2019

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Roche Diabetes Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process change control

What the company is doing

In a Quality Notification dated December 19, 2018, the firm informed its distribution centers of the issue. Contact Centers were provided with updated troubleshooting guides for Aviva II and Performa II meters in August 2018 with instructions for phone solving power issues for meters produced between June 2016 and June 2017. The firm has taken corrective actions to address the issue. Customers should contact Accu-Chek Customer Care line at 1-800-358-4866, Monday through Friday, between the hours of 8:00 am and 8:00 pm Eastern Standard Time

Recall details

Recall number
Z-2766-2019
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 12, 2017
Posted by the FDA
Sep 30, 2019
Recalling firm
Roche Diabetes Care, Inc.
Product code
NBW
FDA submissions
K133862
Distribution
Worldwide distribution - US Nationwide distribution.

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

1 device cleared under K133862 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 83574).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page