Z-0749-2020 Class II Terminated
FDA device recall Z-0749-2020 was initiated by Roche Diabetes Care, Inc. on Sep 30, 2019 and is designated Class II. Reason for recall: Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. The recall status is terminated (terminated Jul 29, 2020). Affected quantity: 21,094.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 8, 2020
- Initiation Date
- Sep 30, 2019
- Termination Date
- Jul 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,094
Product Description
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.
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 : 07400942001 Device Identifier: 00365702702066 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0749-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026