Device product
Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - 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.
Z-0748-2020
Product summary
- Event
- Event 84119
- Status
- Terminated
- Classification
- Class II
- Quantity
- 215,259
- Official record key
device-enforcement:Z-0748-2020
Official wording
Reason: Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
Code information: Model Number : 07400926001 Device Identifier: 00365702702042 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.