Device product

ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020

Z-0999-2020

December 11, 2019

Class II

Product summary

Firm: Roche Diabetes Care, Inc.
Event: Event 84518
Status: Terminated
Classification: Class II
Quantity: 61,329 units (OUS)
Official record key: device-enforcement:Z-0999-2020

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: 498287

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