ACCU-CHEK Aviva Nano Blood Glucose Meter No product labeling, beyond the labels applied to the meter, was provided with
FDA device recall Z-1386-2012 · posted 2012-04-09 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- 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
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 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.
- Date initiated
- 2012-03-12
- Date posted
- 2012-04-09
- Date terminated
- 2012-11-06
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GLUCOSE TEST SYSTEM (K113137) | Roche Diagnostics | 2012-01-06 |