Company:Roche Diagnostics Operations, Inc.
Date of Enforcement Report 3/23/2016
Class lI:
PRODUCT
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. This system should only be use with single-use, auto-disabling lancing devices. Recall Number Z-1172-2016
REASON
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.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Operations, Inc. Indianapolis, IN on 3/14/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
US 5,604 devices, OUS 91,925
DISTRIBUTION
Nationwide
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