Z-0747-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 8, 2020
- Initiation Date
- September 30, 2019
- Termination Date
- July 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 318,678
Product Description
Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE 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.
Reason for Recall
Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.
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.
Code Information
Model Number : 07400870001 Device Identifier: 00365702702035 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).