Recall Z-1172-2016— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-1172-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-11

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2016-02-11, terminated 2017-05-30. It names one FDA 510(k) clearance: K121679. Product: 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. This system should only be use with single-use, auto-disabling lancing devices.. 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: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-02-11
Terminated: 2017-05-30
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K121679 — ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics·cleared 2012-10-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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. This system should only be use with single-use, auto-disabling lancing devices.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.