Recall Z-1172-2016
Roche Diagnostics Operations, Inc. · initiated February 11, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model/Catalog/Part Number: 05060290001; serial numbers: UU41000000 through UU41064963 and UU41064964 through UU41122741.
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.
FDA-determined cause: Software Design Change
Action taken
Roche sent an URGENT MEDICAL DEVICE RECALL CORRECTION letter dated February 11, 2016, via UPS Ground (receipt required) to the consignee. The Consignee instructions were as follows: If currently using USB connectivity, follow the instructions outlined in this Urgent Medical Device Correction (UMDC) to determine if your base unit is affected by the issue. Until the new software is available, do not use USB connectivity if the base unit is affected by this issue; switch the connectivity method to Ethernet (TCP/IP) or Wi-Fi. Roche is not requesting return of affected product. Any returned product will be managed according to current procedures. Consignees with questions were instructed to contact the ACCU-CHEK Customer Care Service Center at 1-800-440-3638. For questions regarding this recall call 317-521-3911.
Details
- Recall number
- Z-1172-2016
- Initiated
- February 11, 2016
- Posted by FDA
- March 14, 2016
- Terminated
- May 30, 2017
- Product code
- LFR – Glucose Dehydrogenase, Glucose
- Quantity
- US 5,604 devices, OUS 91,925
- 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.
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN