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Roche Diabetes Care, Inc. recalls Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
Recalled September 1, 2021 · FDA recall Z-2354-2021 · Roche Diabetes Care
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. · FDA Class II
Units
9,555,555 (US); 5,128,758 (OUS)
Sold at
Worldwide distribution - US Nationwide distribution.
Description
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.
Product
Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
Manufacturer(s)
Roche Diabetes Care, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →