FDAFDA · Food and drugs·Recall number Z-1172-2016
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.
Published March 23, 2016 · Recall initiated: February 11, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Distributor
- 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.
- Lot
- Model/Catalog/Part Number: 05060290001; serial numbers: UU41000000 through UU41064963 and UU41064964 through UU41122741.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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