Class 2 Device Recall ACCUCHEK Aviva Nano Blood Glucose Meter

• Date Initiated by Firm: March 12, 2012
• Date Posted: April 09, 2012
• Recall Status: Terminated on November 06, 2012
• Recall Number: Z-1386-2012
• Recall Event ID: 61405
• 510(K)Number: K113137
• Product Classification: System, test, blood glucose, over the counter - Product Code NBW
• Product: ACCU-CHEK Aviva Nano Blood Glucose Meter ; ; No product labeling, beyond the labels applied to the meter, was provided with the meter as these meters were never intended to be distributed. A representative copy of product labeling that would have been included in a finished device kit is attached.; ; The Accu-Chek Aviva Nano Blood Glucose meter is intended to be used with Accu-Chek Aviva test strips for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The system is intended to be used by a single person and should not be shared. The 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 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).
• Code Information: 05075572002, 05075599002, 05075602002, 05075629002, Part numbers: 05180848002, 05075246002, 05075530002, 05075548002, 05075556002, 05075564002 these are not finished device part numbers and were not intended for use in the US.
• Recalling Firm/ Manufacturer: Roche Diagnostics Operations, Inc.; 9115 Hague Road; Indianapolis IN 46256-1025
• For Additional Information Contact: Todd Siesky; 317-521-3966
• Manufacturer Reason for Recall: Accu-Chek Aviva Nano Blood Glucose meters that were manufactured for the purpose of validating a manufacturing process for product to be distributed outside the US were distributed in the US through eBay by an unauthorized third party. These meters were not intended for distribution, were not verified to meet final product specifications and were not distributed to customers with the necessary pr
• FDA Determined Cause: Employee error
• Action: Roche sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated March 14, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to immediately return their ACCU-CHEK Aviva Nano Meter to the firm in an enclosed pre-paid envelope via USPS. Contact Roche Product Removal Services at 1-888-345-5352 between 8:00 am and 5:00 pm for questions regarding this notice.
• Quantity in Commerce: 82 meter distributed on Ebay
• Distribution: Nationwide Distribution-USA (nationwide) including the states of AZ, NY, RI, TN, NJ, IN, TX, AL, NV, CA, OR, KY, IL, AR, NM, NE, MD, MO, GA, and SD.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NBW and Original Applicant = Roche Diagnostics