FDAFebruary 11, 2016device

Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. T...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The issue can lead to the data loss or in the worst case to an erroneous assignment of the patient data (patient mismatch). The issue will only occur at sites using POTCT1-A communication via USB.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnostics operationsrocheroche diagnostics

UPCs

05060290001

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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