Roche Diabetes Care, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0749-2020)
See the recall detail below. You can also see other recalls from the same firm in 2020.
Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
Class II
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Model Number : 07400942001 Device Identifier: 00365702702066 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).
US Nationwide distribution and countries of AR, AT, AU, BE, BR, CA, CH, CL, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, ID, IN, IT, JP, KR, LB, LT, LU, MM, MY, NL, NO, PH, PK, PT, SE, SG, TH, TW, ZA.
Voluntary: Firm initiated