Z-2353-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 1, 2021
- Initiation Date
- July 28, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,150,755 (US)
Product Description
Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
Reason for Recall
Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.
Distribution Pattern
Worldwide distribution - US Nationwide distribution.
Code Information
Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.