FDA-Device2021-09-01Class II
Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
Roche Diabetes Care, Inc.
Hazard
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.
Sold states
Worldwide distribution - US Nationwide distribution.
Affected count
1,150,755 (US)
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2353-2021Don't want to check this manually?
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