Z-1172-2016 Class II Terminated
FDA device recall Z-1172-2016 was initiated by Roche Diagnostics Operations, Inc. on Feb 11, 2016 and is designated Class II. 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 recall status is terminated (terminated May 30, 2017). Affected quantity: US 5,604 devices, OUS 91,925.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 23, 2016
- Initiation Date
- Feb 11, 2016
- Termination Date
- May 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US 5,604 devices, OUS 91,925
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.
Distribution Pattern
Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV.
Code Information
Model/Catalog/Part Number: 05060290001; serial numbers: UU41000000 through UU41064963 and UU41064964 through UU41122741.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1172-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026