Recall Z-1386-2012 ยท NBW System, Test, Blood Glucose, Over The Counter
Roche Diagnostics Operations, Inc.
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
| Date | Apr 9, 2012 (initiated Mar 12, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113137 | GLUCOSE TEST SYSTEM Roche Diagnostics, Jan 6, 2012 |