medical Class II Updated 2021-09-01

Roche Diabetes Care, Inc. recalls Accu-Chek Inform II Test Strip, Whole Blood Glucose Test Sys

Recalled Product

Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Since this is a labeling correction, this recall is not lot specific and is applicable to all non-expired lots.
View official government recall

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