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
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling the Accu-Chek Inform II Base Unit, which is part of the Accu-Chek Inform II Blood Glucose Monitoring System. The base unit may produce transmission errors that cause data loss when communicating with Data Management Systems via USB using POTCT1-A communication. In the worst case, this could result in patient data being incorrectly assigned to the wrong patient. The recall affects 5,604 devices in the U.S. and 91,925 devices outside the U.S., distributed nationwide across all states and territories. The affected units have model number 05060290001 with serial numbers ranging from UU41000000 through UU41122741.
The recall record does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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. Quantity: US 5,604 devices, OUS 91,925 Lot/code info: Model/Catalog/Part Number: 05060290001; serial numbers: UU41000000 through UU41064963 and UU41064964 through UU41122741.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.