Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
Reported: September 1, 2021 Initiated: July 28, 2021 #Z-2353-2021
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.
Details
- Recalling Firm
- Roche Diabetes Care, Inc.
- Units Affected
- 1,150,755 (US)
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001. Recalled by Roche Diabetes Care, Inc.. Units affected: 1,150,755 (US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 1, 2021. Severity: Moderate. Recall number: Z-2353-2021.
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