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Recall Observatory FDA recall evidence

Device product

Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001

Z-0998-2020

December 11, 2019

Class II

Product summary

Firm
Roche Diabetes Care, Inc.
Event
Event 84518
Status
Terminated
Classification
Class II
Quantity
92,836 vials
Official record key
device-enforcement:Z-0998-2020

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:498315 NDC: 65702-0407-10 UPC: 3-65702-40710-7

Distribution pattern: Nationwide: Foreign: Austalia, India

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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