FDA Medical Device Recalls (openFDA)
Roche Diabetes Care, Inc.: Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
- Recall number
- Z-0997-2020
- Recalling firm
- Roche Diabetes Care, Inc.
- Product
- Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
- Status
- Terminated
- Initiated
- 2019-12-11
- Posted
- not on file
- Terminated
- 2022-07-08
- Reason
- Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
- Root cause
- Process control
- Action
- Roche Diabetes Care issued Urgent Medical Device Corrections via UPS Ground mail to the patients and distributors on 12/11/2019. Letter states reason for recall, health risk and action to take: Immediately discontinue using test strip lots 497864 and 498315. Affected test strips must be discarded. To get replacement test strips, or for questions regarding this notification, use one of the following options: For fastest replacement of your product, please submit your request at https://notices.accu-chek.com. Email Accu-Chek Customer Care at accu-chek.care@roche.com and include the following information: your name, full mailing address, phone number, test strip lot number and number of affected test strip vials. o Contact our 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. If a Business Reply Form was included with this notification, please complete and return it by U.S. mail using the provided postage paid envelope. Please keep this notification for future reference. Distributors/Suppliers instructed as follows: Discontinue distribution and destroy any remaining stock of the affected lots (497864 and 498315) immediately. make this notification available to consumer customers to whom you distributed affected product. If you have distributed affected product to other suppliers, provide a copy of this UMDC to those suppliers. Have those customers report the quantity of product destroyed to you.
- Quantity
- 82,332 vials
- Distribution
- Nationwide: Foreign: Austalia, India
- Lot, serial or model codes
- Lot Number: 497864 NDC: 65702-0438-10 UPC: 3-65702-43810-1
- 510(k) numbers
- ["K131029"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 3011393376
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28