FDA Enforcement
Class II
Terminated
ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
Recall: Z-0999-2020
·
Reported February 12, 2020
Enforcement
- Recall Number
- Z-0999-2020
- Event ID
- 84518
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Roche Diabetes Care, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 12, 2020
- Initiation Date
- December 11, 2019
- Classification Date
- February 5, 2020
- Termination Date
- July 8, 2022
- Address
- 9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States
Description
ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
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 Info
Lot Number: 498287
Distribution
Nationwide: Foreign: Austalia, India
Quantity
61,329 units (OUS)