Z-2352-2021 Class II Ongoing
FDA device recall Z-2352-2021 was initiated by Roche Diabetes Care, Inc. on Jul 28, 2021 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 146,854 (US); 59,815,555 (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Sep 1, 2021
- Initiation Date
- Jul 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 146,854 (US); 59,815,555 (OUS)
Product Description
Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2352-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026