Device product
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
Z-0997-2020
Product summary
- Event
- Event 84518
- Status
- Terminated
- Classification
- Class II
- Quantity
- 82,332 vials
- Official record key
device-enforcement:Z-0997-2020
Official wording
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
Code information: Lot Number: 497864 NDC: 65702-0438-10 UPC: 3-65702-43810-1
Distribution pattern: Nationwide: Foreign: Austalia, India
Derived failure modes
-
Unknown
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