Accu-Chek Fastclix 05864666160Recalls & reported problems
Roche Diabetes Care GmbH · Accu-Chek Fastclix MO/RP/AST Kit USA · Class 2
All models of Accu-Chek Fastclix (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Accu-Chek Fastclix lancing kit is a single-patient-use finger-prick device for people with diabetes. The 72 reports mostly describe a lancet that protrudes beyond the end cap of the device; in one case the user said she pricked herself and bled but did not need medical attention. No deaths and no injuries are reported, and no recalls name this device.
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
- 70
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00365702481107), received between Sep 9, 2019 and Oct 17, 2025 — classified as 70 malfunctions.
The most frequently reported specific device problem is “Retraction Problem” (70 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 Problem70
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- No Consequences Or Impact To Patient27
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
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 23322866 ↗MalfunctionOct 29, 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 20557966 ↗MalfunctionSep 10, 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 20182796 ↗MalfunctionMay 17, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE. THE USER REPORTED THAT THIS HAPPENED WITH TWO DIFFERENT LANCET DRUMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19341412 ↗MalfunctionApr 24, 2024Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE LANCET PROTRUDED BEYOND THE END CAP OF THE DEVICE ON TWO OCCASIONS. WHEN THIS HAPPENED FOR THE FIRST TIME, THE CUSTOMER HURT HERSELF AND BLED, BUT DID NOT NEED MEDICAL ATTENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19177008 ↗MalfunctionMar 14, 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 18904329 ↗MalfunctionDec 22, 2023Retraction 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 18383070 ↗MalfunctionSep 29, 2023Retraction 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 17842373 ↗MalfunctionSep 28, 2023Retraction Problem; Retraction Problem
UPON REVIEW BY THE MANUFACTURER'S INVESTIGATION UNIT, IT WAS FOUND THAT THE LANCET PROTRUDES BEYOND THE END CAP OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17839679 ↗MalfunctionAug 25, 2023Retraction 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 17624352 ↗MalfunctionJun 5, 2023Retraction 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 17063316 ↗MalfunctionMay 22, 2023Retraction 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 16972977 ↗MalfunctionMar 7, 2023Retraction 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 16495521 ↗MalfunctionJan 23, 2023Retraction 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 16224600 ↗MalfunctionSep 30, 2022Retraction 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 15520510 ↗MalfunctionSep 2, 2022Retraction 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 15348719 ↗MalfunctionJul 27, 2022Retraction 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 15112105 ↗MalfunctionMay 26, 2022Retraction 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 14516312 ↗MalfunctionMay 18, 2022Retraction 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 14427049 ↗MalfunctionApr 15, 2022Retraction 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 14118302 ↗MalfunctionApr 13, 2022Retraction 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 14104843 ↗MalfunctionMar 31, 2022Retraction 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 13963486 ↗MalfunctionMar 8, 2022Retraction 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 13688900 ↗MalfunctionMar 3, 2022Retraction 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 13658098 ↗MalfunctionFeb 17, 2022Retraction 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 13547288 ↗
Other Multiple Use Blood Lancet For Single Patient Use Only devices
- 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 Fastclix 07523211001Roche Diabetes Care GmbH · Multiple Use Blood Lancet For Single Patient Use Only44 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.
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