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U.S. Department of Health and Human Services

Class 2 Device Recall AccuChek Inform II Blood Glucose Monitoring System.

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  Class 2 Device Recall AccuChek Inform II Blood Glucose Monitoring System. see related information
Date Initiated by Firm February 11, 2016
Date Posted March 14, 2016
Recall Status1 Terminated 3 on May 30, 2017
Recall Number Z-1172-2016
Recall Event ID 73253
510(K)Number K121679  
Product Classification Glucose dehydrogenase, glucose - Product Code LFR
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.
Code Information Model/Catalog/Part Number: 05060290001; serial numbers: UU41000000 through UU41064963 and UU41064964 through UU41122741.
Recalling Firm/
Manufacturer
Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Todd Siesky
317-521-3911
Manufacturer 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 2
Software Design Change
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LFR and Original Applicant = Roche Diagnostics
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