Recall Z-0997-2020 ยท NBW System, Test, Blood Glucose, Over The Counter
Roche Diabetes Care, Inc.
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
| Date | Dec 11, 2019 |
| Status | Terminated |
| 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 in |
| Quantity | 82,332 vials |
| Distribution | Nationwide: Foreign: Austalia, India |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131029 | ACCU-CHEK AVIVA PLUS TEST STRIP Roche Diagnostics Operations, Inc., Aug 9, 2013 |