UnratedMedical device recall · FDA · Published September 30, 2019
Roche Accu-Chek Guide Blood Glucose Kit: Potential Power Issues
Roche recalls Accu-Chek Guide Blood Glucose Monitoring System model 08453063001 due to potential power issues. Affected units have serial numbers below XXX11000001. No remedy specified in recall notice.
“Roche Accu-Chek Guide Blood Glucose Kit: Potential Power Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66938-roche-accu-chek-guide-blood-glucose-kit-potential-power-issues. Based on FDA recall #Z-0751-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0751-2020%22&limit=1).
Roche Diabetes Care, Inc. voluntarily recalled the Accu-Chek Guide Blood Glucose Monitoring System due to potential power issues, according to a Food and Drug Administration announcement on Sept. 30, 2019.
How to tell if you have it
Brand: Roche
Product: ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US
Model Number: 08453063001
Device Identifier: 00365702728103
Serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number)
The hazard
The recall addresses potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System, which is intended for in vitro diagnostic single-patient use by people with diabetes to measure glucose in fresh capillary whole blood.
Context
GovInfoNow's records show Roche Diabetes Care, Inc. has had nine other recalls on record since June 8, 2017. Other recent recalls of similar products include the Roche Accu-Chek Guide (SC) Kit recall on May 13, 2024, and the Roche Diabetes Care Software Version 2.5.2 recall on March 9, 2022. Recent recalls of similar devices include the FreeStyle Libre 14 Day Sensor Recall on Nov. 24, 2025, and the Beta Bionics iLet Bionic Pancreas Software recall on March 12, 2026.
How to tell if you have this one
Check the serial number on your device. Affected units have serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number). The model number is 08453063001.
Brand
Roche
Category
Medical device
FDA recall event · 6 products
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
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.
Recall number
Product, codes & lots
Quantity
Z-0747-2020
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.; Model Number : 07400870001 Device Identifier: 00365702702035 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).
318,678
Z-0748-2020
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.; Model Number : 07400926001 Device Identifier: 00365702702042 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).
215,259
Z-0749-2020
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.; Model Number : 07400942001 Device Identifier: 00365702702066 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).
21,094
Z-0750-2020
Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN 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.; Model Number : 08453071001 Device Identifier: 00365702729100 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).
3,996
Z-0751-2020
Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN 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.; Model Number : 08453063001 Device Identifier: 00365702728103 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).
355,400
Z-0752-2020
Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - 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.; Model Number : 08313202001 Device Identifier: 00365702702349 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).
452,392
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Look for the serial number on your device. Affected units have serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0751-2020 (September 30, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0751-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.