ACCU-CHEK GUIDE 07453744001Recalls & reported problems

Roche Diagnostics Operations, Inc. · ACCU-CHEK GUIDE 100CT STRIP 24/CS · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Accu-Chek Guide blood glucose test strip has 371 reports, with no deaths and 10 injuries. Most describe incorrect or inconsistent readings, with some reports of several results taken minutes apart that differ widely. No recalls name this device. Recent reports fell from 48 to 27 compared with the period before.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 368
Deaths reported: 0
Injuries reported: 10
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 368 adverse event reports that list this exact device (DI 00365702712102), received between Sep 4, 2019 and Apr 23, 2026 — classified as 10 injuries, 358 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (275 reports).

2 other recalls 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Incorrect, Inadequate or Imprecise Result or Readings275
High Test Results42
Imprecise or Erratic Results40
Low Test Results7
Adverse Event Without Identified Device or Use Problem2
Labelling, Instructions for Use or Training Problem2

Patient problems

No Clinical Signs, Symptoms or Conditions264
No Consequences Or Impact To Patient50
Hypoglycemia20
No Known Impact Or Consequence To Patient10
Hyperglycemia8
Fatigue7
Diaphoresis3
Dizziness3

Recent adverse event reports

The 25 most recent of 368 reports, in the reporter's own words as published by the FDA.

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 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 ↗
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 9, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: "900 MG/DL" AND 250 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24547249 ↗
MalfunctionMar 3, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 237 MG/DL (SYSTEM 1), 97 MG/DL (SYSTEM 2) AND 102 MG/DL (SYSTEM 1).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24495872 ↗
MalfunctionFeb 24, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 66 MG/DL AND 111 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427531 ↗
MalfunctionFeb 16, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 253 MG/DL AND 92 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343941 ↗
MalfunctionFeb 16, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: LO AT 9:50AM, (= LOWER THAN 20 MG/DL) LO AT 9:51AM, LOT AT 9:51AM, LO AT 9:52AM, 123 MG/DL AT 9:55AM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343901 ↗
MalfunctionFeb 6, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 450 MG/DL AT 4:00PM, HI MG/DL AT 4:01PM (WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL), 341 MG/DL AT 4:02PM, 327 MG/DL AT 4:03PM, 241 MG/DL AT 4:04PM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24275909 ↗
MalfunctionJan 20, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 177 MG/DL (B)(6) 2026 1:19 PM, 507 MG/DL (B)(6) 2026 1:18 PM, 236 MG/DL (B)(6) 2026 1:13 PM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24117577 ↗
MalfunctionJan 9, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 8.32 PM - 138 MG/DL, 8.33 PM - 71 MG/DL, 8.44 PM - 122 MG/DL, 8.45PM - 62 MG/DL, 8.46 PM - 55 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24026489 ↗
MalfunctionJan 9, 2026High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 421 MG/DL, 285 MG/DL, AND 144 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24026115 ↗
MalfunctionJan 6, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: A RESULT OF EITHER "HI" MG/DL (GREATER THAN 600 MG/DL) OR "LO" MG/DL (LESS THAN 10 MG/DL) AND 97 MG/DL.THE PATIENT COULDN'T RECALL IF THE RESULT WAS "HI" MG/DL OR "LO" MG/DL, BUT IT WAS ONE OF THE TWO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23980007 ↗
MalfunctionJan 5, 2026Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 80 MG/DL AND 300 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23956521 ↗
MalfunctionDec 23, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 362 MG/DL AND 154 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23875875 ↗
MalfunctionDec 11, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 199 MG/DL, 142 MG/DL AND 101 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778374 ↗
MalfunctionDec 5, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 206 MG/DL AND 110 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23726887 ↗
MalfunctionDec 4, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 9:00AM=571 MG/DL, 9:05AM=31 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23713264 ↗
MalfunctionNov 20, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 7:44 P.M. 279, 7:45 P.M. 207, 7:46 P.M. 200, 7:50 P.M. 421, 7:54 P.M. 198, THE PATIENT WAS USING 2 TEST STRIP LOT NUMBERS. IT IS UNKNOWN WHICH LOT NUMBER WAS USED FOR WHICH BLOOD GLUCOSE RESULT. ONE TEST STRIP LOT NUMBER WAS UNKNOWN. THE OTHER TEST STRIP LOT NUMBER WAS (104870).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23609399 ↗
MalfunctionNov 17, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 320 MG/DL AND 134 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569580 ↗
MalfunctionNov 10, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 201 MG/DL AND 455 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23510600 ↗
MalfunctionNov 3, 2025High Test Results; High Test Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 395 MG/DL AT 7:40AM. 104 MG/DL AT 7:41AM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23451663 ↗
MalfunctionOct 31, 2025Imprecise or Erratic Results; Imprecise or Erratic Results
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 682 MG/DL, 134 MG/DL, AND 130 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23439247 ↗

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, Classified
Accu-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
Z-0747-2020 · Sep 30, 2019 · Terminated
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 quan

Device details

UDI-DI	`00365702712102`
Brand	ACCU-CHEK GUIDE
Model	07453744001
Company	Roche Diagnostics Operations, Inc.
Product code	LFR · Glucose Dehydrogenase, Glucose
Class	Class 2
FDA submission	K160944
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Glucose IVD, reagent

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.

Other Glucose Dehydrogenase, Glucose devices

OneTouch Verio IQ 022-275
LifeScan Europe GmbH · Glucose dehydrogenase, glucose
6,035 reports
OneTouch Verio 022-659
LifeScan Europe GmbH · Glucose dehydrogenase, glucose
4,219 reports
TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 50 Test Strips
Trividia Health, Inc. · Glucose Dehydrogenase, Glucose
2 deaths2,548 reports
FreeStyle Lite 70805
Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose
2,366 reports
FreeStyle Freedom Lite 70920
Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose
1,037 reports
FreeStyle Freedom Lite 70914
Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose
760 reports
Accu-Chek Guide 08256292001
Roche Diagnostics Operations, Inc. · Glucose Dehydrogenase, Glucose
476 reports
ACCU-CHEK AVIVA PLUS 06908268001
Roche Diagnostics Operations, Inc. · Glucose Dehydrogenase, Glucose
472 reports

All Glucose Dehydrogenase, Glucose devices →

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 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page