ACCU-CHEK GUIDERecalls & reported problems across all models
Roche Diagnostics Operations, Inc. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one ACCU-CHEK GUIDE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,416
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls
- 6
We found 14 models of ACCU-CHEK GUIDE by Roche Diagnostics Operations, Inc. in the FDA's device registry (GUDID). Together they are named in 1,416 adverse event reports in the FDA's MAUDE database, received between Sep 4, 2019 and Sep 28, 2026 — classified as 50 injuries, 1,366 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1,020 reports).
6 FDA recall records name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ACCU-CHEK GUIDE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 13, 2024Open, Classified
The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approximately 18 times lower that the actual blood glucose. Potential immediate health consequences of the glucose meter providing a reading in the wrong units of measurement (UOM) may result in inappropriate rescue therapy for presumed hypoglycemia including urgent and repeat administration of carbohydrates. This in turn could lead to frequent episodes of hyperglycemia which is unrecognized and undertreated.Long range consequences of continued use of the affected meters could include mismanagement of the patient s diabetes for longer periods of time potentially resulting in a major health event (in general persistent and/or severe hyperglycemia) that may lead them to seek medical attention, and depending on the duration of hyperglycemia, could contribute to the development of microvascular (i.e., retinopathy, neuropathy, nephropathy) and/or macrovascular (i.e., myocardial infarction, ischemic stroke) complications of diabetes and could lead to fetal damage (abnormal fetal growth and altered organ development and maturation, fetal hypoxemia, spontaneous abortion, and congenital anomalies) in pregnant women. This issue was identified by three initial consumer complaints, with reports that the meters were presenting the incorrect unit of measure.
Z-2174-2024 · Root cause: Reprocessing Controls · Recall details · FDA record ↗
- Sep 30, 2019Terminated
Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
Z-0751-2020 · Root cause: Device Design · Recall details · FDA record ↗
- Sep 30, 2019Terminated
Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
Z-0750-2020 · Root cause: Device Design · Recall details · FDA record ↗
- Sep 30, 2019Terminated
Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
Z-0749-2020 · Root cause: Device Design · Recall details · FDA record ↗
- Sep 30, 2019Terminated
Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
Z-0748-2020 · Root cause: Device Design · Recall details · FDA record ↗
- Sep 30, 2019Terminated
Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
Z-0747-2020 · Root cause: Device Design · Recall details · FDA record ↗
Most reported ACCU-CHEK GUIDE problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1,020
- Imprecise or Erratic Results147
- High Test Results131
- Display or Visual Feedback Problem50
- Low Test Results19
- Adverse Event Without Identified Device or Use Problem11
- Labelling, Instructions for Use or Training Problem5
- Melted5
Patient problems
- No Clinical Signs, Symptoms or Conditions1,013
- No Consequences Or Impact To Patient188
- Hypoglycemia94
- Hyperglycemia40
- No Known Impact Or Consequence To Patient31
- Fatigue16
- Dizziness15
- Shaking/Tremors15
ACCU-CHEK GUIDE models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Accu-Chek Guide 08256292001Glucose Dehydrogenase, Glucose476 reports
- ACCU-CHEK GUIDE 07453736001Glucose Dehydrogenase, Glucose410 reports
- ACCU-CHEK GUIDE 07453744001Glucose Dehydrogenase, Glucose368 reports
- Accu-Chek Guide 08453071001System, Test, Blood Glucose, Over The Counter2 recalls0 reports
- Accu-Chek Guide 07398794001System, Test, Blood Glucose, Over The Counter61 reports
- ACCU-CHEK GUIDE 07400870001System, Test, Blood Glucose, Over The Counter1 recall0 reports
- ACCU-CHEK GUIDE 07400926001System, Test, Blood Glucose, Over The Counter1 recall0 reports
- ACCU-CHEK GUIDE 07400942001System, Test, Blood Glucose, Over The Counter1 recall0 reports
- Accu-Chek Guide 08453063001System, Test, Blood Glucose, Over The Counter1 recall0 reports
- Accu-Chek Guide 08053723001Glucose Dehydrogenase, Glucose42 reports
- Accu-Chek Guide 07453710001Glucose Dehydrogenase, Glucose25 reports
- Accu-Chek Guide 08387052001System, Test, Blood Glucose, Over The Counter22 reports
- ACCU-CHEK GUIDE 07453701001Glucose Dehydrogenase, Glucose9 reports
- ACCU-CHEK GUIDE 08053774001Glucose Dehydrogenase, Glucose3 reports
Recent ACCU-CHEK GUIDE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917613 ↗MalfunctionSep 28, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917546 ↗MalfunctionSep 25, 2026High Test Results
It was reported the patient received the following results within 15 minutes: 479 mg/dL and 126 mg/dL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897028 ↗MalfunctionApr 23, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 247 MG/DL, 121 MG/DL, AND 138 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972364 ↗MalfunctionApr 20, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 300 MG/DL AND 125 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24924304 ↗MalfunctionApr 17, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 256 MG/DL, 350 MG/DL AND 130 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24906997 ↗MalfunctionApr 16, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 399 MG/DL AND 131 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899616 ↗MalfunctionApr 9, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 210 MG/DL AND 101 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831145 ↗MalfunctionApr 8, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 317 MG/DL AT 12:41PM, 86 MG/DL AT 12:43PM.
Patient problems: Fatigue
MAUDE report 24817702 ↗MalfunctionApr 8, 2026Overheating of Device
IT WAS REPORTED THAT THE BATTERIES EXPLODED WITHIN THE METER. THE BATTERY DOOR CANNOT BE OPENED BECAUSE IT IS BURNT AND THE BATTERIES CAN BE SEEN FROM THE EDGES OF THE DOOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24813003 ↗MalfunctionMar 30, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: "LO" MG/DL (LESS THAN 20 MG/DL) AND 265 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714325 ↗MalfunctionMar 20, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 317MG/DL AT 10:00AM, 116MG/DL AT 10:01AM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649735 ↗MalfunctionMar 19, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 84 MG/DL (SYSTEM 1) AND 163 MG/DL (SYSTEM 2). THE BLOOD GLUCOSE RESULTS WERE OBTAINED USING THE SAME VIAL OF TEST STRIPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641174 ↗MalfunctionMar 19, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 150 MG/DL, 130 MG/DL, 110 MG/DL, 50 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637344 ↗MalfunctionMar 11, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: LO (= LOWER THAN THE MEASUREMENT RANGE OF THE METER) AND 119 MG/DL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24574608 ↗
Other Roche Diagnostics Operations, Inc. products
All Roche Diagnostics Operations, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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