Accu-Chek Fastclix 07523211001Recalls & reported problems
Roche Diabetes Care GmbH · Accu-Chek Fastclix Device Bulk 100 · Class 2
All models of Accu-Chek Fastclix (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is the Accu-Chek Fastclix lancing device, a finger-prick tool that uses a spring-loaded lancet to draw a drop of blood for glucose testing. The 46 adverse event reports all describe the same mechanical issue: the lancet sticking out past the end cap instead of retracting, sometimes causing pain to the finger. No deaths and no injuries were reported, and there are no recalls naming this device. Reports have slowed recently, with 5 in the past 12 months compared to 16 in the year 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
- 44
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 04015630065615), received between Sep 6, 2023 and Mar 20, 2026 — classified as 44 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (44 reports).
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
Most reported problems
Device problems
- Retraction Problem44
Patient problems
- No Clinical Signs, Symptoms or Conditions44
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647574 ↗MalfunctionFeb 10, 2026Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24304469 ↗MalfunctionNov 11, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23522717 ↗MalfunctionOct 20, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23343166 ↗MalfunctionOct 17, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23320754 ↗MalfunctionOct 16, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23309442 ↗MalfunctionJul 22, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22563722 ↗MalfunctionJul 8, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22437701 ↗MalfunctionJul 7, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE. THE ISSUE OCCURRED AGAIN WITH A NEW LANCET DRUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22414148 ↗MalfunctionMay 30, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE. THE PATIENT REPORTED THAT SHE PRICKED HER FINGER DUE TO THE PROTRUDING LANCET BUT DID NOT REQUIRE MEDICAL TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22115243 ↗MalfunctionApr 22, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21880748 ↗MalfunctionMar 18, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21628712 ↗MalfunctionFeb 24, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21446073 ↗MalfunctionFeb 11, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21356469 ↗MalfunctionFeb 6, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21322202 ↗MalfunctionFeb 3, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21292982 ↗MalfunctionJan 23, 2025Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21217809 ↗MalfunctionNov 28, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20804721 ↗MalfunctionNov 26, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20786567 ↗MalfunctionOct 24, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20521675 ↗MalfunctionOct 15, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20457047 ↗MalfunctionSep 24, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE. THE ISSUE OCCURRED 11 TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20290777 ↗MalfunctionSep 3, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20129368 ↗MalfunctionAug 26, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20067036 ↗MalfunctionJul 23, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED, THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19812091 ↗
Other Multiple Use Blood Lancet For Single Patient Use Only devices
- Accu-Chek Fastclix 05864666160Roche Diabetes Care GmbH · Multiple Use Blood Lancet For Single Patient Use Only70 reports
- One +Step LF-TL-28-IShandong Lianfa Medical Plastic Products CO.,LTD · Multiple Use Blood Lancet For Single Patient Use Only1 recall0 reports
- One +Step LF-TL-23-IShandong Lianfa Medical Plastic Products CO.,LTD · Multiple Use Blood Lancet For Single Patient Use Only1 recall0 reports
- One +Step LF-TL-30-IIShandong Lianfa Medical Plastic Products CO.,LTD · Multiple Use Blood Lancet For Single Patient Use Only1 recall0 reports
- Accu-Chek Coaguchek Softclix 07313462001Roche Diabetes Care GmbH · Multiple Use Blood Lancet For Single Patient Use Only46 reports
- Accu-Chek Coaguchek Softclix 08120242001Roche Diabetes Care GmbH · Multiple Use Blood Lancet For Single Patient Use Only11 reports
- Accu-Chek Fastclix 05360145001Roche Diabetes Care GmbH · Multiple Use Blood Lancet For Single Patient Use Only7 reports
- MICROLET® 6586 / 6586WAscensia Diabetes Care US Inc. · Multiple Use Blood Lancet For Single Patient Use Only3 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 · 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