Z-0999-2020 Class II Terminated
FDA device recall Z-0999-2020 was initiated by Roche Diabetes Care, Inc. on Dec 11, 2019 and is designated Class II. Reason for recall: 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 The recall status is terminated (terminated Jul 8, 2022). Affected quantity: 61,329 units (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 12, 2020
- Initiation Date
- Dec 11, 2019
- Termination Date
- Jul 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61,329 units (OUS)
Product Description
ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020
Reason for Recall
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
Distribution Pattern
Nationwide: Foreign: Austalia, India
Code Information
Lot Number: 498287
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0999-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026