ACCU-CHEK GUIDE 07400870001Recalls & reported problems
Roche Diagnostics Operations, Inc. · ACCU-CHEK GUIDE SAMPLE KIT MG/DL · Class 2
All models of ACCU-CHEK GUIDE (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
1 other recall cover devices cleared under the same FDA submission (K160944); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Sep 30, 2019Class IITerminated
Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
Z-0747-2020 · Root cause: Device Design · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K160944. One submission often covers many models, so check the product and lot details in each record.
- Z-2174-2024 · May 13, 2024 · Open, ClassifiedAccu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectivenes
Other System, Test, Blood Glucose, Over The Counter devices
- OneTouch Verio Flex 023-271LifeScan Europe GmbH · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER3,703 reports
- FreeStyle Libre 2 71953Abbott Diabetes Care Inc · System, test, blood glucose, over the counter2 recalls1 death3,286 reports
- OneTouch Ultra2 021-105LifeScan U.S. LLC · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER1,731 reports
- Omnipod DASH PDM PDM-USA1-D001-MG-USA1Insulet Corporation · System, Test, Blood Glucose, Over The Counter1 recall10 deaths1,129 reports
- Omnipod UST400Insulet Corporation · System, Test, Blood Glucose, Over The Counter12 deaths816 reports
- TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER - NOT FOR RETAIL SALETrividia Health, Inc. · System, Test, Blood Glucose, Over The Counter418 reports
- FreeStyle Freedom Lite 70923-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
- FreeStyle Lite 70829-70Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER378 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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